Instrument
Restoration ADM Trial Insert 28/46- NOT Compatible With MDM
7manufacturers in China registered for this device type
136catalogue numbers in this listing
1510(k) clearance
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-05-10 (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 54 mm; outer diameter 36 to 66 mm; length 9 to 260 mm |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0581-1-260 | Length 260.0 mm | In distribution |
| 0939-1-112M | Thickness: 12.0 Millimeter | In distribution |
| 1119-2100 | In distribution | |
| 1601-1590 | In distribution | |
| I-H1551HF00 | In distribution | |
| 2208-2058A | Diameter: 58.0 Millimeter | In distribution |
| 1030-2658 | Outer Diameter 58.0 mm | In distribution |
| 0581-1-352 | Size: 0 | In distribution |
| 2210-26E | Alpha Code: E | In distribution |
| 2208-4051 | Diameter: 51.0 Millimeter | In distribution |
| 0581-1-044 | Length 125.0 mm | In distribution |
| 2208-2064A | Diameter: 64.0 Millimeter | In distribution |
| 6278-8-322 | Diameter: 22.0 Millimeter | In distribution |
| 6825-2-240 | Lumen/Inner Diameter 22.0 mm | In distribution |
| I-H2108PL62 | Diameter: 62.0 Millimeter | In distribution |
| 1100-1240 | Taper Connection: C-TPR | In distribution |
| 1100-3275R | Head Diameter: 32.0 Millimeter | In distribution |
| 2200-32B | Degree: 0.0 Degree | In distribution |
| 4845-2-958 | Size: 8 | In distribution |
| 1601-26132 | Degree: 132.0 Degree | In distribution |
| I-H1645HA00 | In distribution | |
| 0581-1-503 | Offset: 50.0 Millimeter | In distribution |
| 1235-0-852 | In distribution | |
| 1235-C-1050 | Taper Connection: C-TPR | In distribution |
| 2200-40F | Degree: 0.0 Degree | In distribution |
| 2102-0451 | Diameter: 51.0 Millimeter | In distribution |
| 1020-5106 | Size: 6 | In distribution |
| 1235-0-522 | Side: LEFT | In distribution |
| 2260-36G | Alpha Code: G | In distribution |
| I-H2108PR48 | Diameter: 48.0 Millimeter | In distribution |
| 2200-26D | Lumen/Inner Diameter 26.0 mm | In distribution |
| I-H21103610 | Diameter: 36.0 Millimeter | In distribution |
| 4845-7-957 | Size: 7 | In distribution |
| I-H1956HA00 | Diameter: 38.0 Millimeter | In distribution |
| 4845-2-964 | Side: LEFT | In distribution |
| 1235-V-0025 | Offset: -2.5 Millimeter | In distribution |
| 1020-2006 | In distribution | |
| 0580-3744-4 | Offset: 44.0 Millimeter | In distribution |
| 2210-28G | Lumen/Inner Diameter 28.0 mm | In distribution |
| 0939-1-120M | Thickness: 20.0 Millimeter | In distribution |
| 1235-C-1000 | Offset: 0.0 Millimeter | In distribution |
| 2107-3360 | Length 60.0 mm | In distribution |
| 6842-6-270 | Taper Connection: V40? | In distribution |
| 2210-36I | Lumen/Inner Diameter 36.0 mm | In distribution |
| 1100-3605R | Head Diameter: 36.0 Millimeter | In distribution |
| 6278-8-320 | Diameter: 20.0 Millimeter | In distribution |
| 1601-1578 | In distribution | |
| 1235-0-501 | Outer Diameter 50.0 mm | In distribution |
| I-H2108ER56 | Diameter: 56.0 Millimeter | In distribution |
| 1100-1335 | Degree: 132.0 Degree | In distribution |
| 2208-4062 | Diameter: 62.0 Millimeter | In distribution |
| I-H1862HB10 | Size: 10 | In distribution |
| 2240-32G | Alpha Code: G | In distribution |
| I-H2108PL60 | Diameter: 60.0 Millimeter | In distribution |
| 1020-2100 | In distribution | |
| 2200-36J | Lumen/Inner Diameter 36.0 mm | In distribution |
| 2208-4074 | Diameter: 74.0 Millimeter | In distribution |
| 6264-8-132R | Head Diameter: 32.0 Millimeter | In distribution |
| 1235-0-521 | Side: RIGHT | In distribution |
| 1020-5155 | Size: 5.5 | In distribution |
| 2200-22D | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2250-32H | Lumen/Inner Diameter 32.0 mm | In distribution |
| 4842-3012 | Diameter: 12.0 Millimeter | In distribution |
| 1100-4010R | Head Diameter: 40.0 Millimeter | In distribution |
| I-H2108ER48 | Diameter: 48.0 Millimeter | In distribution |
| 1235-0-846 | In distribution | |
| 4845-7-970 | Side: LEFT | In distribution |
| 6278-8-319 | Diameter: 19.0 Millimeter | In distribution |
| I-H1698HF0R | Side: RIGHT | In distribution |
| 1030-1201 | In distribution | |
| 1110-0911 | In distribution | |
| 2208-4077 | Diameter: 77.0 Millimeter | In distribution |
| 2208-6063L | Side: LEFT | In distribution |
| 2200-26H | Lumen/Inner Diameter 26.0 mm | In distribution |
| 1235-4-465 | In distribution | |
| 1235-0-242M | Alpha Code: C | In distribution |
| 0580-33 | Offset: 33.0 Millimeter | In distribution |
| 6842-6-260 | Taper Connection: V40? | In distribution |
| 2250-28G | Alpha Code: G | In distribution |
| 1030-1200 | In distribution | |
| I-H1433HF00 | In distribution | |
| 6825-9-955 | Outer Diameter 55.0 mm | In distribution |
| 2200-22C | Alpha Code: C | In distribution |
| 1020-5204 | Size: 4 | In distribution |
| 1020-1870 | In distribution | |
| 2260-32E | Alpha Code: E | In distribution |
| 1235-V-1080 | Offset: 8.0 Millimeter | In distribution |
| 6264-8-732R | Taper Connection: V40? | In distribution |
| 6264-8-436R | Taper Connection: V40? | In distribution |
| I-H21103202 | Offset: -2.5 Millimeter | In distribution |
| 1150-2347 | Outer Diameter 47.0 mm | In distribution |
| 5097-6215 | Outer Diameter 62.0 mm | In distribution |
| 1212-0009 | Length 9.0 mm | In distribution |
| 1100-1340 | Taper Connection: C-TPR | In distribution |
| 2210-22H | Alpha Code: H | In distribution |
| 3200-48G | Alpha Code: G | In distribution |
| 1150-2342 | Outer Diameter 42.0 mm | In distribution |
| 1235-0-000 | In distribution | |
| 1440-2010 | In distribution | |
| 1150-2349 | Outer Diameter 49.0 mm | In distribution |
| 2208-4069 | Diameter: 69.0 Millimeter | In distribution |
| 2210-22C | Lumen/Inner Diameter 22.0 mm | In distribution |
| I-H21103675 | Diameter: 36.0 Millimeter | In distribution |
| 3200-54I | Lumen/Inner Diameter 54.0 mm | In distribution |
| 0581-1-501 | Size: 1 | In distribution |
| 2250-28H | Alpha Code: H | In distribution |
| 2200-36E | Lumen/Inner Diameter 36.0 mm | In distribution |
| 1030-3266 | Outer Diameter 66.0 mm | In distribution |
| 2102-0445 | Diameter: 45.0 Millimeter | In distribution |
| 4845-2-962 | Size: 2 | In distribution |
| 0581-1-372 | Size: 2 | In distribution |
| 2208-4060S | Diameter: 60.0 Millimeter | In distribution |
| 2210-26F | Alpha Code: F | In distribution |
| 6264-8-426R | Offset: 12.0 Millimeter | In distribution |
| 0581-1-446 | Size: 6 | In distribution |
| 1235-0-848 | In distribution | |
| 0580-375-1 | Size: 1 | In distribution |
| 2240-22G | Degree: 0.0 Degree | In distribution |
| 1030-2650 | Outer Diameter 50.0 mm | In distribution |
| I-H1382H340 | Offset: 8.0 Millimeter | In distribution |
| 1235-4-605 | In distribution | |
| 2102-0465 | Diameter: 65.0 Millimeter | In distribution |
| I-H16194025 | Length 25.0 mm | Withdrawn |
| I-H0659HA76 | Diameter: 76.0 Millimeter | Withdrawn |
| I-H0659HA46 | Diameter: 46.0 Millimeter | Withdrawn |
| I-H1435H36D | Alpha Code: D | Withdrawn |
| I-H1157032D | Lumen/Inner Diameter 32.0 mm | Withdrawn |
| I-H1552HA60 | Diameter: 4.0 Millimeter | Withdrawn |
| I-H0659HA73 | Diameter: 73.0 Millimeter | Withdrawn |
| I-H08452057 | Diameter: 57.0 Millimeter | Withdrawn |
| I-H1605HA47 | Diameter: 47.0 Millimeter | Withdrawn |
| I-H1157136G | Alpha Code: G | Withdrawn |
| I-H0659HA71 | Diameter: 71.0 Millimeter | Withdrawn |
| I-H1268TH05 | Diameter: 36.0 Millimeter | Withdrawn |
| I-H0921HA01 | Withdrawn | |
| I-H0659HA52 | Diameter: 52.0 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arcos Modular Revision System | Biomet Orthopedics | 48 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Restoration | Howmedica Osteonics Corp | 29 |
| Arcos | Biomet Orthopedics | 19 |
| Echo® Bi-Metric® Hip System | Biomet Orthopedics | 18 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| OrthoMedFlex | Orthomedflex LLC | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
| Regenerex® Ringloc®+ Hip System | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123604 | 2013-08-16 |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 8487 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 71 units. | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 207 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 1936 units | 2006-04-05 |
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.