Kinematic
Rotating Hinge Knee
7manufacturers in China registered for this device type
7catalogue numbers in this listing
9510(k) clearances naming this product code
3recalls 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 | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K002552 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6485-4-121 | Size: SM | In distribution |
| 6485-4-111 | Size: SM | In distribution |
| 6485-8-435 | In distribution | |
| 6485-4-221 | Size: MED | In distribution |
| 6485-4-116 | Thickness: 16.0 Millimeter | In distribution |
| 6485-4-113 | Thickness: 13.0 Millimeter | In distribution |
| 6485-4-213 | Size: MED | 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 |
|---|---|
| K122015 | 2013-02-22 |
| K060360 | 2006-03-15 |
| K040749 | 2004-06-17 |
| K031480 | 2003-07-31 |
| K023087 | 2002-12-16 |
| K002552 | 2000-11-13 |
| K001957 | 2000-07-25 |
| K001548 | 2000-06-07 |
| K994207 | 2000-03-13 |
Recalls Naming This Product
17 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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy –The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy –The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2007-11-15 | Not classified | Process design | Curvature Discrepancy — The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. | 803 total, all sizes | 2008-09-22 |
| Howmedica Osteonics Corp | 510(k) number | 2003-01-07 | Not classified | Other | Some components have disassociated post-operatively resulting in additional surgery to the patient. | 136 | 2003-07-31 |
| Howmedica Osteonics Corp | 510(k) number | 2003-01-07 | Not classified | Other | Some components have disassociated post-operatively resulting in additional surgery to the patient. | 311 | 2003-07-31 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| 2009-01-30 | Not classified | Labeling False and Misleading | Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components. | 1161 units | 2010-04-08 |
| 2005-05-05 | Not classified | Labeling mix-ups | Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece. | 5 units | 2010-10-01 |
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.