Instrument
Cutting Edge Advantage Secur-FIT Omnifit EON Broach C8/PF10
31manufacturers in China registered for this device type
70catalogue numbers in this listing
5510(k) clearances naming this product code
30recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-05-10 (version 8) |
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 42 to 66 mm; depth 40 mm; width 0.5 in |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2101-0132 | In distribution | |
| 1150-2345 | Outer Diameter 45.0 mm | In distribution |
| 5097-6220 | Outer Diameter 62.0 mm | In distribution |
| 5097-5815 | Thickness: 15.0 Millimeter | In distribution |
| 0930-6-002 | In distribution | |
| 2260-28F | Alpha Code: F | In distribution |
| 2208-4044S | Diameter: 44.0 Millimeter | In distribution |
| 0580-300-0 | Offset: 30.0 Millimeter | In distribution |
| 1150-2346 | Outer Diameter 46.0 mm | In distribution |
| 2200-44G | Alpha Code: G | In distribution |
| 1235-V-1060 | Offset: 6.0 Millimeter | In distribution |
| I-H2108ER60 | Diameter: 60.0 Millimeter | In distribution |
| 1030-2242 | Outer Diameter 42.0 mm | In distribution |
| 1030-1600 | In distribution | |
| 1235-0-848M | In distribution | |
| 6842-6-120 | In distribution | |
| 1100-4000R | Head Diameter: 40.0 Millimeter | In distribution |
| 1440-2019 | In distribution | |
| 2208-4047 | Diameter: 47.0 Millimeter | In distribution |
| 1020-5211 | Size: 11 | In distribution |
| 2260-36F | Lumen/Inner Diameter 36.0 mm | In distribution |
| 2124-1750 | Side: LEFT | In distribution |
| 5097-6620 | Thickness: 20.0 Millimeter | In distribution |
| 2200-28H | Degree: 0.0 Degree | In distribution |
| 1030-2858 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 1150-2351 | Outer Diameter 51.0 mm | In distribution |
| 2260-28E | Lumen/Inner Diameter 28.0 mm | In distribution |
| 4845-2-961 | Side: LEFT | In distribution |
| 2111-0036 | Diameter: 36.0 Millimeter | In distribution |
| 2210-28I | Degree: 10.0 Degree | In distribution |
| 1110-0810 | In distribution | |
| 6264-8-128R | Taper Connection: V40? | In distribution |
| 2102-0475 | Diameter: 75.0 Millimeter | In distribution |
| 1020-5200 | Size: 0 | In distribution |
| 2102-0467 | Diameter: 67.0 Millimeter | In distribution |
| 0581-1-561 | Size: 1 | In distribution |
| 2240-28F | Degree: 0.0 Degree | In distribution |
| 1150-2361 | Outer Diameter 61.0 mm | In distribution |
| 2210-22G | Alpha Code: G | In distribution |
| 6088-9-800 | Depth 40.0 mm | In distribution |
| 1100-1330 | Taper Connection: C-TPR | In distribution |
| 2102-0410 | In distribution | |
| 1030-2860 | Outer Diameter 60.0 mm | In distribution |
| 1020-5100 | Size: 0 | In distribution |
| 2260-36H | Alpha Code: H | In distribution |
| 1030-2646 | Outer Diameter 46.0 mm | In distribution |
| 1235-0-864 | In distribution | |
| 1100-4025R | Offset: 2.5 Millimeter | In distribution |
| 1020-5101 | Size: 1 | In distribution |
| HI-UHRK-22 | In distribution | |
| 2210-36H | Degree: 10.0 Degree | In distribution |
| 1030-2852 | Outer Diameter 52.0 mm | In distribution |
| 2102-0436 | Diameter: 36.0 Millimeter | In distribution |
| 1020-2003 | In distribution | |
| 2107-0014 | In distribution | |
| 0580-3744-1 | Size: 1 | In distribution |
| 1601-1210 | In distribution | |
| 1020-2727 | Diameter: 27.0 Millimeter | In distribution |
| 2200-44H | Alpha Code: H | In distribution |
| 2107-3300 | Diameter: 3.3 Millimeter | In distribution |
| 5097-6615 | Outer Diameter 66.0 mm | In distribution |
| 2210-36G | Alpha Code: G | In distribution |
| 1235-0-858M | In distribution | |
| 1030-2856 | Outer Diameter 56.0 mm | In distribution |
| 1235-0-461 | Outer Diameter 46.0 mm | In distribution |
| 1100-2200R | Head Diameter: 25.0 Millimeter | In distribution |
| I-H08452055 | Diameter: 55.0 Millimeter | Withdrawn |
| I-H0659HA49 | Diameter: 49.0 Millimeter | Withdrawn |
| I-H0496HA00 | Width 0.5 in | Withdrawn |
| I-H0659HA55 | Diameter: 55.0 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071092 | 2007-05-11 |
| K024060 | 2002-12-20 |
| K023294 | 2002-10-09 |
| K002654 | 2000-09-22 |
| K000080 | 2000-04-03 |
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 |
|---|---|---|---|---|---|
| 2013-10-10 | Class II | Device Design | Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. | 118 units | 2016-04-21 |
| 2013-10-01 | Class II | Labeling mix-ups | Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. | Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1 | 2015-07-15 |
| 2013-07-08 | Class II | Process control | Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. | 23 units | 2015-03-31 |
| 2012-08-17 | Class II | Mixed-up of materials/components | Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may con | Approximately 72 units | 2014-04-10 |
| 2012-08-17 | Class II | Mixed-up of materials/components | Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may con | Approximately 358 units | 2014-04-10 |
| 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 |
| 2009-06-26 | 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 |
| 2005-12-20 | Not classified | Labeling mix-ups | The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length. | 29 units | 2008-09-23 |
| 2005-10-04 | Not classified | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a po | 171 units | 2006-05-04 |
| 2005-10-04 | Not classified | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a po | 2465 units | 2006-05-04 |
| 2005-10-04 | Not classified | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a po | 3548 units | 2006-05-04 |
| 2005-10-04 | Not classified | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a po | 532 units | 2006-05-04 |
| 2005-10-04 | Not classified | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a po | 34,839 units | 2006-05-04 |
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.