Orthopedic Salvage System (OSS)
69 catalogue numbers from CP111275, 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
69catalogue 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) | K002757 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
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 | Status |
|---|---|---|
| CP111275 | 4 CM | In distribution |
| CP102838 | 3 CM | In distribution |
| 161031 | 18 MM RS | In distribution |
| 151814 | 67 MM | In distribution |
| CP102514 | 71 MM | In distribution |
| 151812 | 59 MM | In distribution |
| CP111820 | 22 CM 9 CM | In distribution |
| 150504 | 14MM Ø 25CM LENGTH | In distribution |
| 161002 | In distribution | |
| CP102839 | 5 CM | In distribution |
| 150508 | 14MM Ø 29CM LENGTH | In distribution |
| 161074 | In distribution | |
| CP114847 | 20 CM 8 CM | In distribution |
| 161072 | In distribution | |
| CP111283 | 17 CM | In distribution |
| 151816 | In distribution | |
| CP102840 | 7 CM | In distribution |
| RD122064 | 20 MM 55/59 MM RS | In distribution |
| 161030 | 16 MM RS | In distribution |
| 161001 | In distribution | |
| 161034 | RS | In distribution |
| CP113455 | In distribution | |
| CP114850 | 23 CM 11 CM | In distribution |
| CP114840 | 24 CM 12 CM | In distribution |
| RD122063 | 20 MM 47/51 MM RS | In distribution |
| CP114839 | 23 CM 11 CM | In distribution |
| 151853 | SMALL SIZE | In distribution |
| CP114834 | 18 CM 6 CM | In distribution |
| CP114831 | 15 CM 3 CM | In distribution |
| 161012 | 7 CM RS | In distribution |
| 161003 | In distribution | |
| CP113462 | 63 MM STANDARD | In distribution |
| CP114837 | 21 CM 9 CM | In distribution |
| CP114843 | 16 CM 4 CM | In distribution |
| CP111831 | 22 CM 9 CM | In distribution |
| CP114852 | 25 CM 13 CM | In distribution |
| CP114838 | 22 CM 10 CM | In distribution |
| CP111276 | 3 CM | In distribution |
| 161032 | 20 MM RS | In distribution |
| CP114851 | 24 CM 12 CM | In distribution |
| CP114833 | 17 CM 5 CM | In distribution |
| CP112061 | 9 MM 150 MM | In distribution |
| CP114846 | 19 CM 7 CM | In distribution |
| CP102848 | 23 CM | In distribution |
| CP102513 | 67 MM | In distribution |
| CP114841 | 25 CM 13 CM | In distribution |
| 161033 | 22 MM RS | In distribution |
| CP160904 | In distribution | |
| CP114848 | 21 CM 9 CM | In distribution |
| CP111823 | 25 CM 12 CM | In distribution |
| CP111280 | 11 CM | In distribution |
| CP114842 | 15 CM 3 CM | In distribution |
| CP114836 | 20 CM 8 CM | In distribution |
| 151834 | 18 MM | In distribution |
| CP114835 | 19 CM 7 CM | In distribution |
| CP114845 | 18 CM 6 CM | In distribution |
| RD122062 | 20 MM 47/51 MM RS | In distribution |
| 161028 | 12 MM RS | In distribution |
| 150503 | 14MM Ø 24CM LENGTH | In distribution |
| RD122060 | 10MM THICK 47/51 MM RS | In distribution |
| CP111281 | 13 CM | In distribution |
| 150502 | 14MM Ø 23CM LENGTH | In distribution |
| RD122061 | 10MM THICK 55/59 MM RS | In distribution |
| CP102522 | 63 MM 11MM Ø 160 MM | In distribution |
| CP114844 | 17 CM 5 CM | In distribution |
| 161029 | 14 MM RS | In distribution |
| CP102521 | 63 MM 10MM Ø 160 MM | In distribution |
| CP114849 | 22 CM 10 CM | In distribution |
| CP114832 | 16 CM 4 CM | 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
26 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 | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 12 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 29 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 28 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 23 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 39 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 30 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2019-07-02 | Class II | Material/Component Contamination | Cleaning processes potentially being ineffective | 19 | 2021-09-10 |
| Biomet, Inc. | 510(k) number | 2018-10-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as th | 3 total | 2020-04-28 |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2016-12-16 | Class II | Under Investigation by firm | labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient unde | 16 | 2017-07-21 |
| Biomet, Inc. | 510(k) number | 2012-03-20 | Not classified | Component design/selection | Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and m | 64 units distributed | 2013-02-07 |
| Biomet, Inc. | 510(k) number | 2011-11-01 | Not classified | Mixed-up of materials/components | Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13×150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14×150). | 3 units & 1 pending release | 2012-09-10 |
| 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 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
| Biomet, Inc. | 510(k) number | 2007-11-07 | Not classified | Labeling mix-ups | Mislabeled as to size: Product is labeled as reduced size, but is actually standard size. | 22 | 2009-03-13 |
| Biomet, Inc. | 510(k) number | 2007-11-07 | Not classified | Labeling mix-ups | Mislabeled as to size: Product is labeled as reduced size, but is actually standard size. | 22 | 2009-03-13 |
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.