Instrument
Specialty V40 Head Trial With Suture Holes 36MM -2.5 Offset
14manufacturers in China registered for this device type
145catalogue numbers in this listing
19510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K211703 |
| Record published | 2016-11-09 |
| Record revised | 2024-09-11 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Lumen/inner diameter 22 to 44 mm; outer diameter 38 to 75 mm; length 10 to 240 mm; length 12 in |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-H2085RG30 | Neck Length: 30.0 Millimeter | In distribution |
| I-H1282HF12 | Taper Connection: V40? | In distribution |
| 1030-1632 | In distribution | |
| I-H0985HA0F | Alpha Code: F | In distribution |
| 2200-44F | Lumen/Inner Diameter 44.0 mm | In distribution |
| I-H1862HB09 | Size: 9 | In distribution |
| 1100-3697R | Taper Connection: C-TPR | In distribution |
| I-H1855BH10 | Size: 10 | In distribution |
| 6264-8-136R | Offset: 0.0 Millimeter | In distribution |
| 1020-2900 | In distribution | |
| I-H1282HF09 | Offset: 5.0 Millimeter | In distribution |
| I-H1387H62H | Diameter: 62.0 Millimeter | In distribution |
| 6278-8-312 | Diameter: 12.0 Millimeter | In distribution |
| 2208-2040A | Diameter: 40.0 Millimeter | In distribution |
| 6090-4-300 | In distribution | |
| 2111-3036 | Diameter: 36.0 Millimeter | In distribution |
| 0939-1-114M | Thickness: 14.0 Millimeter | In distribution |
| I-H1749HFSL | Side: LEFT | In distribution |
| 1100-2800R | Taper Connection: C-TPR | In distribution |
| I-H0985HA0A | Alpha Code: A | In distribution |
| 6278-8-324 | Diameter: 24.0 Millimeter | In distribution |
| 4845-2-966 | Size: 6 | In distribution |
| 2210-22F | Alpha Code: F | In distribution |
| 1601-1532 | Size: LGE | In distribution |
| 2208-2054A | Diameter: 54.0 Millimeter | In distribution |
| I-H0929H283 | Diameter: 28.0 Millimeter | In distribution |
| I-H21103602 | Diameter: 36.0 Millimeter | In distribution |
| I-H1288HA0A | Alpha Code: A | In distribution |
| 2101-0004 | In distribution | |
| 6842-6-125 | In distribution | |
| 2208-4052S | Diameter: 52.0 Millimeter | In distribution |
| 1030-1500 | In distribution | |
| I-H1282HF02 | Diameter: 36.0 Millimeter | In distribution |
| 6825-9-944 | Outer Diameter 44.0 mm | In distribution |
| 6278-8-321 | Diameter: 21.0 Millimeter | In distribution |
| 7002-0143 | Diameter: 43.0 Millimeter | In distribution |
| 7002-0155 | Diameter: 55.0 Millimeter | In distribution |
| 1601-1004A | Size: 4 | In distribution |
| 2270-28F | Diameter: 28.0 Millimeter | In distribution |
| 6264-8-328R | Head Diameter: 28.0 Millimeter | In distribution |
| 1030-3254 | Outer Diameter 54.0 mm | In distribution |
| 2208-4072 | Diameter: 72.0 Millimeter | In distribution |
| 1030-3263 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 1030-1626 | In distribution | |
| I-H2108PL56 | Diameter: 56.0 Millimeter | In distribution |
| 6266-0-140 | In distribution | |
| 2240-36F | Degree: 0.0 Degree | In distribution |
| I-H1288HA0D | Alpha Code: D | In distribution |
| I-H1288HA0H | Alpha Code: H | In distribution |
| 4845-7-958 | Side: RIGHT | In distribution |
| I-H1206HF00 | In distribution | |
| 0581-1-373 | Offset: 37.5 Millimeter | In distribution |
| I-H0929H266 | Offset: 16.0 Millimeter | In distribution |
| 2200-28B | Diameter: 28.0 Millimeter | In distribution |
| 2208-4056 | Diameter: 56.0 Millimeter | In distribution |
| 2111-0032 | Diameter: 32.0 Millimeter | In distribution |
| 4845-2-953 | Side: RIGHT | In distribution |
| 1212-0013 | Length 13.0 mm | In distribution |
| 2208-4055 | Diameter: 55.0 Millimeter | In distribution |
| 6090-4-315 | In distribution | |
| 1235-0-012 | In distribution | |
| 4845-2-954 | Side: RIGHT | In distribution |
| 2208-2070A | Diameter: 70.0 Millimeter | In distribution |
| 1601-1008A | Size: 8 | In distribution |
| 6090-5-305 | In distribution | |
| I-H0929H285 | Offset: 12.0 Millimeter | In distribution |
| 5097-5025 | Thickness: 25.0 Millimeter | In distribution |
| 1235-4-485 | In distribution | |
| I-H2108PR46 | Diameter: 46.0 Millimeter | In distribution |
| 1235-0-244 | Alpha Code: D | In distribution |
| 2250-28F | Alpha Code: F | In distribution |
| 1601-1005A | Size: 5 | In distribution |
| 1100-1330S | Taper Connection: C-TPR | In distribution |
| 6090-4-310 | In distribution | |
| 2210-22B | Lumen/Inner Diameter 22.0 mm | In distribution |
| I-H2108PL54 | Diameter: 54.0 Millimeter | In distribution |
| I-H1282HF08 | Offset: 8.0 Millimeter | In distribution |
| 1235-V-1030 | Offset: 3.0 Millimeter | In distribution |
| 1235-0-846M | In distribution | |
| 2200-32G | Degree: 0.0 Degree | In distribution |
| 2230-22E | Alpha Code: E | In distribution |
| 1235-0-502 | Outer Diameter 50.0 mm | In distribution |
| 2260-36J | Diameter: 36.0 Millimeter | In distribution |
| 7002-0157 | Diameter: 57.0 Millimeter | In distribution |
| 6278-8-326 | Diameter: 26.0 Millimeter | In distribution |
| 0581-1-505 | Taper Connection: V40? | In distribution |
| 7002-0164 | Diameter: 64.0 Millimeter | In distribution |
| I-H1961H361 | Offset Standard: Standard | In distribution |
| 1235-0-244M | Lumen/Inner Diameter 22.2 mm | In distribution |
| 2102-0459 | Diameter: 59.0 Millimeter | In distribution |
| 8000-7705 | Size: 5 | In distribution |
| 2208-6075L | Side: LEFT | In distribution |
| 2200-36I | Lumen/Inner Diameter 36.0 mm | In distribution |
| 2102-0462 | Diameter: 62.0 Millimeter | In distribution |
| I-H1282HF10 | Offset: 4.0 Millimeter | In distribution |
| 2240-32D | Alpha Code: D | In distribution |
| 1020-3235 | Diameter: 35.0 Millimeter | In distribution |
| 2200-28A | Diameter: 28.0 Millimeter | In distribution |
| 6869-1-000 | Length 12.0 in | In distribution |
| 5097-5425 | Outer Diameter 54.0 mm | In distribution |
| 1150-2338 | Outer Diameter 38.0 mm | In distribution |
| 7002-0156 | Diameter: 56.0 Millimeter | In distribution |
| 2230-28G | Degree: 10.0 Degree | In distribution |
| 2250-36G | Degree: 10.0 Degree | In distribution |
| 2208-4067 | Diameter: 67.0 Millimeter | In distribution |
| 2200-32J | Lumen/Inner Diameter 32.0 mm | In distribution |
| I-H1282H240 | Offset: 4.0 Millimeter | In distribution |
| I-H1282HF06 | Taper Connection: V40? | In distribution |
| 2270-22D | Alpha Code: D | In distribution |
| I-H1855BH00 | Size: 0 | In distribution |
| 2102-0471 | Diameter: 71.0 Millimeter | In distribution |
| 6842-6-265 | Offset Standard: Standard | In distribution |
| I-H1749HFLL | Size: LGE | In distribution |
| I-H1282HF11 | Offset: 4.0 Millimeter | In distribution |
| I-H0929H282 | Diameter: 28.0 Millimeter | In distribution |
| 6278-1-360 | In distribution | |
| 2200-32D | Alpha Code: D | In distribution |
| 1212-0010 | Length 10.0 mm | In distribution |
| 6264-8-232R | Offset: 4.0 Millimeter | In distribution |
| 1100-2205R | Offset: 5.0 Millimeter | In distribution |
| 2102-0446 | Diameter: 46.0 Millimeter | In distribution |
| 1440-2003 | In distribution | |
| 4845-2-963 | Side: LEFT | In distribution |
| 1440-1050 | In distribution | |
| 2111-3032 | Diameter: 32.0 Millimeter | In distribution |
| I-H1387H48D | Diameter: 48.0 Millimeter | In distribution |
| 2200-28F | Alpha Code: F | In distribution |
| 1100-4405R | Offset: 5.0 Millimeter | In distribution |
| 1113-1003 | Size: LGE | In distribution |
| 2200-32I | Lumen/Inner Diameter 32.0 mm | In distribution |
| 0581-1-240 | Size: 3 | In distribution |
| I-H1268TH15 | Diameter: 36.0 Millimeter | Withdrawn |
| I-H10043325 | Diameter: 3.3 Millimeter | Withdrawn |
| I-H1157036F | Lumen/Inner Diameter 36.0 mm | Withdrawn |
| I-H1316HF00 | Withdrawn | |
| I-H0659HA43 | Diameter: 43.0 Millimeter | Withdrawn |
| I-H1157128D | Degree: 10.0 Degree | Withdrawn |
| I-H0659HA40 | Diameter: 40.0 Millimeter | Withdrawn |
| I-H0659HA79 | Diameter: 79.0 Millimeter | Withdrawn |
| I-H0659HA48 | Diameter: 48.0 Millimeter | Withdrawn |
| I-H1157136F | Alpha Code: F | Withdrawn |
| I-H0659HA60 | Diameter: 60.0 Millimeter | Withdrawn |
| I-H1969AG00 | Withdrawn | |
| I-H1961H362 | Taper Connection: V40? | Withdrawn |
| I-H20212740 | Taper Connection: C-TPR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
| Esop® | Fournitures Hospitalieres Industrie | 120 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122853 | 2013-02-01 |
| K112556 | 2011-09-28 |
| K093644 | 2009-12-18 |
| K092406 | 2009-11-04 |
| K092561 | 2009-10-20 |
| K091161 | 2009-06-16 |
| K082892 | 2008-12-29 |
| K081044 | 2008-06-03 |
| K072020 | 2007-10-18 |
| K032300 | 2003-10-09 |
| K023102 | 2002-10-09 |
| K020615 | 2002-05-13 |
| K020572 | 2002-03-04 |
| K013676 | 2001-12-05 |
| K001448 | 2000-08-04 |
| K994366 | 2000-03-16 |
| K993768 | 2000-01-21 |
| K993077 | 1999-10-08 |
| K992025 | 1999-08-13 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| 2014-12-15 | Class II | Process control | Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. | seven units | 2016-09-22 |
| 2014-02-03 | Class II | Error in labeling | Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem – Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem – Right S | 48 units | 2014-12-02 |
| 2012-10-23 | Class II | Labeling mix-ups | Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. | 6021-2530- four units; 6021-3535- | 2013-09-11 |
| 2012-04-30 | Class II | Device Design | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting an | 9003 units | |
| 2012-04-30 | Class II | Device Design | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting an | (NLS/NLV) – 23193 units and (SPT) – 20,743 units | |
| 2011-10-27 | Not classified | Error in labeling | An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8. | 31 Units | 2013-08-22 |
| 2011-09-06 | Not classified | Packaging | As part of Stryker’s quality process, a packaging discrepancy was identified in specific lots of Stryker’s Duration packaging. | 39,483 units | 2015-11-17 |
| 2011-07-14 | Not classified | Mixed-up of materials/components | Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem. | 21 units | 2013-11-15 |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-08-02 | Not classified | Device Design | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. | 2012-11-09 | |
| 2010-01-21 | Not classified | Other | The Restoration ADM Trial Cup Holder may not have been assembled correctly. | 5 units | 2012-06-20 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. | 51,113 total – all sizes. | 2010-07-27 |
| 2009-01-14 | Not classified | Device Design | Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument. | 786 total stems | 2012-07-18 |
| 2009-01-14 | Not classified | Device Design | Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument. | 786 total stems | 2012-07-18 |
| 2009-01-06 | Not classified | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity. | 1,628 total stems, all varieties. | 2012-06-25 |
| 2009-01-06 | Not classified | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity. | 1,628 total stems, all varieties. | 2012-06-25 |
| 2009-01-06 | Not classified | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity. | 1,628 total stems, all varieties. | 2012-06-25 |
| 2009-01-06 | Not classified | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity. | 1,628 total stems, all varieties. | 2012-06-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.