DJO Surgical
INS,KNEE,EMPOWR Partial Knee Tibial Insert Trial, Sz 5, 12mm
6manufacturers in China registered for this device type
107catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | 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 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191325 |
| Record published | 2020-05-19 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801-06-069 | In distribution | |
| 801-06-041 | In distribution | |
| 357-01-101 | In distribution | |
| 801-06-062 | In distribution | |
| 347-08-701 | In distribution | |
| 347-10-705 | In distribution | |
| 800-06-005 | In distribution | |
| 801-06-047 | In distribution | |
| 357-02-105 | In distribution | |
| 347-12-703 | In distribution | |
| 247-01-105 | In distribution | |
| 247-01-102 | In distribution | |
| 357-02-104 | In distribution | |
| 347-09-706 | In distribution | |
| 800-06-035 | In distribution | |
| 347-12-702 | In distribution | |
| 801-06-058 | In distribution | |
| 800-06-027 | In distribution | |
| 800-06-001 | In distribution | |
| 801-06-057 | In distribution | |
| 800-06-026 | In distribution | |
| 800-06-036 | In distribution | |
| 357-02-101 | In distribution | |
| 347-08-704 | In distribution | |
| 800-06-032 | In distribution | |
| 801-06-071 | In distribution | |
| 801-06-017 | In distribution | |
| 247-02-104 | In distribution | |
| 347-12-704 | In distribution | |
| 801-06-061 | In distribution | |
| 247-02-101 | In distribution | |
| 801-06-050 | In distribution | |
| 801-06-070 | In distribution | |
| 801-06-048 | In distribution | |
| 247-01-101 | In distribution | |
| 801-06-042 | In distribution | |
| 347-09-702 | In distribution | |
| 801-06-067 | In distribution | |
| 247-02-102 | In distribution | |
| 801-06-066 | In distribution | |
| 801-06-053 | In distribution | |
| 801-06-052 | In distribution | |
| 800-06-003 | In distribution | |
| 347-10-701 | In distribution | |
| 800-06-037 | In distribution | |
| 801-06-063 | In distribution | |
| 801-06-060 | In distribution | |
| 801-06-059 | In distribution | |
| 800-06-029 | In distribution | |
| 247-01-106 | In distribution | |
| 347-08-702 | In distribution | |
| 801-06-073 | In distribution | |
| 801-06-044 | In distribution | |
| 357-01-105 | In distribution | |
| 357-02-102 | In distribution | |
| 801-06-051 | In distribution | |
| 357-01-103 | In distribution | |
| 347-10-704 | In distribution | |
| 347-10-703 | In distribution | |
| 247-02-103 | In distribution | |
| 357-02-103 | In distribution | |
| 801-06-065 | In distribution | |
| 801-06-064 | In distribution | |
| 347-08-703 | In distribution | |
| 247-01-104 | In distribution | |
| 347-09-701 | In distribution | |
| 357-01-106 | In distribution | |
| 347-09-704 | In distribution | |
| 347-10-706 | In distribution | |
| 347-10-702 | In distribution | |
| 800-06-004 | In distribution | |
| 800-06-034 | In distribution | |
| 800-06-031 | In distribution | |
| 347-08-706 | In distribution | |
| 800-06-006 | In distribution | |
| 801-06-055 | In distribution | |
| 801-06-043 | In distribution | |
| 247-02-105 | In distribution | |
| 801-06-046 | In distribution | |
| 347-08-705 | In distribution | |
| 800-06-025 | In distribution | |
| 801-06-039 | In distribution | |
| 357-02-106 | In distribution | |
| 347-12-701 | In distribution | |
| 347-09-705 | In distribution | |
| 347-12-706 | In distribution | |
| 247-02-106 | In distribution | |
| 801-06-056 | In distribution | |
| 800-06-023 | In distribution | |
| 800-06-022 | In distribution | |
| 800-06-002 | In distribution | |
| 247-01-103 | In distribution | |
| 347-12-705 | In distribution | |
| 800-06-030 | In distribution | |
| 801-06-072 | In distribution | |
| 357-01-104 | In distribution | |
| 347-09-703 | In distribution | |
| 801-06-054 | In distribution | |
| 801-06-049 | In distribution | |
| 357-01-102 | In distribution | |
| 801-06-045 | In distribution | |
| 800-06-033 | In distribution | |
| 801-06-068 | In distribution | |
| 800-06-028 | In distribution | |
| 801-06-038 | In distribution | |
| 800-06-024 | In distribution | |
| 801-06-040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191325 | 2019-07-16 |
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 |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2020-06-19 | Class II | Other | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the d | 28 units |
| Encore Medical, L.P. | 510(k) number | 2020-06-19 | Class II | Other | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the d | 28 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.