Compress Device
19 catalogue numbers from 178577, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
19catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| 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 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K062998 |
| Record published | 2015-10-24 |
| Record revised | 2026-03-25 (version 8) |
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 |
|---|---|---|---|
| 178577 | 1 CM 38 MM SMALL SIZE | In distribution | |
| 178736 | 26MM Ø | In distribution | |
| 178432 | 1 CM 38MM Ø SMALL SIZE | In distribution | |
| 178410 | 20 MM STANDARD | In distribution | |
| 178480 | 1 CM 38MM Ø SMALL SIZE | In distribution | |
| 178524 | 20MM LENGTH | 6 | In distribution |
| 178727 | 8.5 CM | In distribution | |
| 178561 | 19 MM | In distribution | |
| 178399 | In distribution | ||
| 178539 | 17MM Ø | In distribution | |
| 178733 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178554 | 12 MM | In distribution | |
| 178363 | 1 CM 30MM Ø X-SMALL SIZE | In distribution | |
| 178496 | 1 CM 44MM Ø LARGE SIZE | In distribution | |
| 178726 | 8.5 CM | In distribution | |
| 178526 | 28MM LENGTH | 6 | In distribution |
| 178724 | 7 CM | In distribution | |
| 178472 | 1 CM 38MM Ø SMALL SIZE | In distribution | |
| 178536 | 14MM Ø | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253515 | 2026-08-24 |
| K023085 | 2002-10-17 |
| K020076 | 2002-01-30 |
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.