Instrument
Cutting Edge Advantage Secur-FIT Omnifit EON Broach C10/PF12
14manufacturers in China registered for this device type
130catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 9 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 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K182468 |
| 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 |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 44 to 75 mm; length 8 to 150 mm; lumen/inner diameter 22 to 38 mm |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2208-4079 | Diameter: 79.0 Millimeter | In distribution |
| I-H21352740 | Neck Length: 40.0 Millimeter | In distribution |
| 2112-0000 | In distribution | |
| 6842-6-275 | Offset: 8.0 Millimeter | In distribution |
| 1100-2675R | Taper Connection: C-TPR | In distribution |
| I-H2108PL64 | Diameter: 64.0 Millimeter | In distribution |
| 1119-0000 | In distribution | |
| 1235-0-481 | Outer Diameter 48.0 mm | In distribution |
| 6825-9-956 | Outer Diameter 56.0 mm | In distribution |
| 0585-9-400 | Offset: 44.0 Millimeter | In distribution |
| 1030-2244 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 5097-5415 | Outer Diameter 54.0 mm | In distribution |
| 6825-9-950 | Outer Diameter 50.0 mm | In distribution |
| 0585-9-444 | Length 150.0 mm | In distribution |
| 1090-3258 | Diameter: 58.0 Millimeter | In distribution |
| 1235-4-505 | In distribution | |
| 1235-4-645 | In distribution | |
| I-H21353235 | Neck Angle: 132.0 Degree | In distribution |
| 0581-1-351 | Taper Connection: V40? | In distribution |
| 1110-0709 | In distribution | |
| 6264-8-440R | Head Diameter: 40.0 Millimeter | In distribution |
| I-H2135BT01 | Size: 1 | In distribution |
| I-H2135BT02 | Size: 2 | In distribution |
| 1020-5135 | Size: 3.5 | In distribution |
| 2260-28D | Alpha Code: D | In distribution |
| I-H21352737 | Neck Length: 37.0 Millimeter | In distribution |
| 2240-22H | Degree: 0.0 Degree | In distribution |
| 2102-0477 | Diameter: 77.0 Millimeter | In distribution |
| I-H2135BT08 | Size: 8 | In distribution |
| 6264-8-322R | Offset: 8.0 Millimeter | In distribution |
| I-H21103640 | Offset: 4.0 Millimeter | In distribution |
| 4845-7-966 | Side: LEFT | In distribution |
| 0585-9-372 | Size: 2 | In distribution |
| 1235-0-641 | Side: RIGHT | In distribution |
| 1020-2740 | Degree: 127.0 Degree | In distribution |
| 0585-9-504 | Offset: 50.0 Millimeter | In distribution |
| I-H2135BT04 | Size: 4 | In distribution |
| 2102-0443 | Diameter: 43.0 Millimeter | In distribution |
| 1235-0-008 | In distribution | |
| 2240-32E | Alpha Code: E | In distribution |
| I-H21353240 | Neck Angle: 132.0 Degree | In distribution |
| 0580-44 | Offset: 44.0 Millimeter | In distribution |
| 1110-1012 | In distribution | |
| 0580-3744-2 | Size: 2 | In distribution |
| 1100-2898R | Taper Connection: C-TPR | In distribution |
| 1235-0-856M | In distribution | |
| 1235-C-1025 | Offset: 2.5 Millimeter | In distribution |
| 2208-6061R | Side: RIGHT | In distribution |
| 0580-3744-3 | Size: 3 | In distribution |
| 0580-375-3 | Size: 3 | In distribution |
| 6825-9-952 | Outer Diameter 52.0 mm | In distribution |
| 3200-38D | Lumen/Inner Diameter 38.0 mm | In distribution |
| I-H2108PL48 | Diameter: 48.0 Millimeter | In distribution |
| 1212-0008 | Length 8.0 mm | In distribution |
| 0581-1-371 | Size: 1 | In distribution |
| I-H2108PR64 | Diameter: 64.0 Millimeter | In distribution |
| 1440-2011 | In distribution | |
| I-H21352727 | Neck Length: 27.0 Millimeter | In distribution |
| 1235-4-585 | In distribution | |
| 1100-3299R | Head Diameter: 32.0 Millimeter | In distribution |
| 1235-0-856 | In distribution | |
| I-H2135BT03 | Size: 3 | In distribution |
| I-H21353230 | Neck Angle: 132.0 Degree | In distribution |
| 2208-2044A | Diameter: 44.0 Millimeter | In distribution |
| 2208-4058 | Diameter: 58.0 Millimeter | In distribution |
| 2210-26G | Alpha Code: G | In distribution |
| 1440-1010 | In distribution | |
| 1100-2610R | Offset: 10.0 Millimeter | In distribution |
| 2102-0440 | Diameter: 40.0 Millimeter | In distribution |
| 2270-32I | Alpha Code: I | In distribution |
| 6264-8-040R | Head Diameter: 40.0 Millimeter | In distribution |
| I-H2108ER58 | Diameter: 58.0 Millimeter | In distribution |
| 1212-0014 | Length 14.0 mm | In distribution |
| 1020-5208 | Size: 8 | In distribution |
| 2208-6075R | Outer Diameter 75.0 mm | In distribution |
| 1235-V-0040 | Offset: -4.0 Millimeter | In distribution |
| 2208-6067L | Side: LEFT | In distribution |
| 1100-2600R | Offset: 0.0 Millimeter | In distribution |
| I-H2135BT00 | Size: 0 | In distribution |
| 0581-1-442 | Taper Connection: V40? | In distribution |
| 0585-9-300 | Length 95.0 mm | In distribution |
| 2200-22G | Alpha Code: G | In distribution |
| 0585-9-371 | Size: 1 | In distribution |
| 1235-0-561 | Side: RIGHT | In distribution |
| 1020-3227 | Diameter: 27.0 Millimeter | In distribution |
| 2210-28C | Alpha Code: C | In distribution |
| 2200-32E | Degree: 0.0 Degree | In distribution |
| 0581-1-300 | Offset: 30.0 Millimeter | In distribution |
| 8000-7711 | Size: 11 | In distribution |
| 1090-2248 | Diameter: 48.0 Millimeter | In distribution |
| 0939-0-002M | Size: Standard | In distribution |
| 1020-1100 | In distribution | |
| 1100-1240S | Taper Connection: C-TPR | In distribution |
| 5097-5020 | Thickness: 20.0 Millimeter | In distribution |
| 8000-7710 | Size: 10 | In distribution |
| 2208-4080 | Diameter: 80.0 Millimeter | In distribution |
| I-H19660300 | Side: LEFT | In distribution |
| 2107-4040 | Diameter: 4.0 Millimeter | In distribution |
| 6090-4-325 | In distribution | |
| I-H2135BT07 | Size: 7 | In distribution |
| 5097-5420 | Thickness: 20.0 Millimeter | In distribution |
| I-H2135BT06 | Size: 6 | In distribution |
| 2210-36E | Alpha Code: E | In distribution |
| I-H2085RG40 | Neck Length: 40.0 Millimeter | In distribution |
| I-H21352730 | Neck Length: 30.0 Millimeter | In distribution |
| 2210-32H | Alpha Code: H | In distribution |
| 1601-1504 | In distribution | |
| I-H2135BT11 | Size: 11 | In distribution |
| 0581-3-371 | Length 125.0 mm | In distribution |
| 2200-28J | Lumen/Inner Diameter 28.0 mm | In distribution |
| 1101-2100 | In distribution | |
| I-H2135BT09 | Size: 9 | In distribution |
| 0580-50 | Offset: 50.0 Millimeter | In distribution |
| 0937-3-215 | Size: SM | In distribution |
| I-H2135BT10 | Size: 10 | In distribution |
| I-H21352735 | Neck Length: 35.0 Millimeter | In distribution |
| I-H21353227 | Neck Angle: 132.0 Degree | In distribution |
| 2210-28F | Degree: 10.0 Degree | In distribution |
| I-H21353237 | Neck Length: 37.0 Millimeter | In distribution |
| 6264-8-944R | Head Diameter: 44.0 Millimeter | In distribution |
| 2270-32H | Degree: 0.0 Degree | In distribution |
| 6825-9-958 | Outer Diameter 58.0 mm | In distribution |
| I-H2135BT05 | Size: 5 | In distribution |
| I-H08452063 | Diameter: 63.0 Millimeter | Withdrawn |
| I-H08452047 | Diameter: 47.0 Millimeter | Withdrawn |
| I-H1157HE00 | Withdrawn | |
| I-H0789HA20 | Diameter: 4.0 Millimeter | Withdrawn |
| I-H1287HA15 | Length 15.0 mm | Withdrawn |
| I-H08452051 | Diameter: 51.0 Millimeter | Withdrawn |
| I-H1385HEX0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-11-08 | Not classified | Employee error | Mislabeled boxes — Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa. | 8 units | 2010-05-13 |
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.