S-ROM Noiles
S-ROM Noiles Rotating Hinge Femoral Rotating Hinge Cemented Right Medium
7manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
11recalls on this 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 | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K241000 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-09 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 62-3401R | In distribution | |
| 62-3411R | In distribution | |
| 62-3411L | 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 |
|---|---|
| K191779 | 2019-10-08 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 129 | 2015-03-03 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 128 | 2015-03-03 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 134 | 2015-03-03 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2014-02-24 | Class II | Packaging | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. | 137 | 2015-03-03 |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-19 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 160 units |
| 2026-05-19 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 66 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
| 2026-04-03 | Class II | Under Investigation by firm | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 3 units |
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.