Unix
17 catalogue numbers from 4510-002L, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
17catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), 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 |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K052917 |
| Record published | 2015-09-24 |
| Record revised | 2019-12-11 (version 4) |
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 |
|---|---|---|
| 4510-002L | Side: LEFT | In distribution |
| 4540-0410 | Thickness: 10.0 Millimeter | In distribution |
| 4540-0112 | Size: 1 | In distribution |
| 4540-0312 | Size: 3 | In distribution |
| 4540-0315 | Thickness: 15.0 Millimeter | In distribution |
| 4540-0108 | Thickness: 8.0 Millimeter | In distribution |
| 4540-0412 | Size: 4 | In distribution |
| 4540-0212 | Thickness: 12.0 Millimeter | In distribution |
| 4540-0310 | Thickness: 10.0 Millimeter | In distribution |
| 4540-0210 | Size: 2 | In distribution |
| 4540-0215 | Size: 2 | In distribution |
| 4540-0208 | Thickness: 8.0 Millimeter | In distribution |
| 4540-0415 | Thickness: 15.0 Millimeter | In distribution |
| 4540-0408 | Size: 4 | In distribution |
| 4540-0115 | Thickness: 15.0 Millimeter | In distribution |
| 4540-0308 | Thickness: 8.0 Millimeter | In distribution |
| 4540-0110 | Thickness: 10.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082567 | 2008-10-03 |
| K071881 | 2007-10-09 |
Recalls Naming This Product
2 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 | 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 | |
| Howmedica Osteonics Corp | 510(k) number | 2011-08-17 | Not classified | Other | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. | 26,648 units | 2014-03-26 |
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 |
|---|---|---|---|---|---|
| 2008-11-25 | Not classified | Labeling mix-ups | Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE. | 8 mm – 1 unit; 12 mm – 8 units. | 2010-08-30 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.