Compress Device
20 catalogue numbers from CP160232, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
20catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| 510(k) | K080330 |
| 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 |
|---|---|---|---|
| CP160232 | X-SHORT SIZE | In distribution | |
| 178579 | 1 CM 44 MM LARGE SIZE | In distribution | |
| 178729 | 10 CM | In distribution | |
| 178543 | 21MM Ø | In distribution | |
| 178718 | 7 CM | In distribution | |
| 178535 | 13MM Ø | In distribution | |
| 178371 | 1 CM 37X49MM Ø ELLIPTICAL | In distribution | |
| 178534 | 60MM LENGTH | 6 | In distribution |
| 178558 | 16 MM | In distribution | |
| 178728 | 10 CM | In distribution | |
| 178400 | 10 MM STANDARD | In distribution | |
| CP160110 | In distribution | ||
| 178566 | 24 MM | In distribution | |
| 178530 | 44MM LENGTH | 6 | In distribution |
| 178725 | 7 CM | In distribution | |
| 178525 | 24MM LENGTH | 6 | In distribution |
| 178512 | In distribution | ||
| 178351 | 1 CM 30MM Ø X-SMALL SIZE | In distribution | |
| 178730 | 1 CM 30 MM X-SMALL SIZE | In distribution | |
| 178562 | 20 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131393 | 2013-10-24 |
| K020381 | 2002-05-06 |
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.