Compress Device
21 catalogue numbers from 178734, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
21catalogue numbers in this listing
2510(k) clearances naming this product 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 | Biomet Orthopedics, 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 |
| 510(k) | K062998 |
| Record published | 2015-10-24 |
| Record revised | 2026-03-25 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 178734 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178570 | 28 MM | In distribution | |
| 178529 | 40MM LENGTH | 6 | In distribution |
| CP112626 | 12 MM | In distribution | |
| 178368 | 1 CM 44MM Ø LARGE SIZE | In distribution | |
| 178364 | 1 CM 30MM Ø X-SMALL SIZE | In distribution | |
| 178352 | 1 CM 30MM Ø X-SMALL SIZE | In distribution | |
| 178372 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178546 | 24MM Ø | In distribution | |
| 178373 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178559 | 17 MM | In distribution | |
| 178737 | 27MM Ø | In distribution | |
| 178360 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178545 | 23MM Ø | In distribution | |
| 178532 | 52MM LENGTH | 6 | In distribution |
| 178556 | 14 MM | In distribution | |
| 178504 | 1 CM 44MM Ø LARGE SIZE | In distribution | |
| 178572 | 68MM LENGTH | 6 | In distribution |
| 178404 | 14 MM STANDARD | In distribution | |
| 178541 | 19MM Ø | In distribution | |
| 178357 | 1 CM 44MM Ø LARGE SIZE | In distribution |
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 |
| Instrument | Howmedica Osteonics Corp | 145 |
| 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 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021403 | 2002-05-31 |
| K020963 | 2002-04-16 |
Recalls Naming This Product
27 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2019-08-21 | Class II | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 219988 units | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2018-10-24 | Class II | Employee error | Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted | 6 units | 2020-04-14 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
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.