Engage
Engage Porous Coated Femoral Size 2-RIGHT Medial
1manufacturer
112catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | NJD |
| Device type | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3535 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190439 |
| Record published | 2023-01-11 |
| Record revised | 2025-07-28 (version 3) |
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 |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: : – |
| Packaging | Box of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-10013-463 | In distribution | |
| 1-50043-609 | In distribution | |
| 1-50043-613 | In distribution | |
| 1-10013-559 | In distribution | |
| 1-10013-610 | In distribution | |
| 1-10013-563 | In distribution | |
| 1-51040-007 | In distribution | |
| 1-51041-006 | In distribution | |
| 1-51031-006 | In distribution | |
| 1-50042-109 | In distribution | |
| 1-50042-610 | In distribution | |
| 1-10012-600 | In distribution | |
| 1-51030-007 | In distribution | |
| 1-51031-003 | In distribution | |
| 1-50042-411 | In distribution | |
| 1-51030-005 | In distribution | |
| 1-50043-610 | In distribution | |
| 1-10013-513 | In distribution | |
| 1-50042-409 | In distribution | |
| 1-50041-006 | In distribution | |
| 1-10013-510 | In distribution | |
| 1-10013-161 | In distribution | |
| 1-10013-459 | In distribution | |
| 1-50042-211 | In distribution | |
| 1-10013-613 | In distribution | |
| 1-50080-001 | In distribution | |
| 1-50042-509 | In distribution | |
| 1-50041-002 | In distribution | |
| 1-50043-410 | In distribution | |
| 1-50040-005 | In distribution | |
| 1-51040-002 | In distribution | |
| 1-10003-110 | In distribution | |
| 1-51031-004 | In distribution | |
| 1-50042-111 | In distribution | |
| 1-50043-310 | In distribution | |
| 1-10011-200 | In distribution | |
| 1-51041-007 | In distribution | |
| 1-10013-659 | In distribution | |
| 1-10003-600 | In distribution | |
| 1-51030-002 | In distribution | |
| 1-10013-462 | In distribution | |
| 1-50060-002 | In distribution | |
| 1-10013-562 | In distribution | |
| 1-50100-445 | In distribution | |
| 1-10013-213 | In distribution | |
| 1-10012-500 | In distribution | |
| 1-51041-004 | In distribution | |
| 1-10013-460 | In distribution | |
| 1-10013-413 | In distribution | |
| 1-50041-001 | In distribution | |
| 1-10003-200 | In distribution | |
| 1-10013-361 | In distribution | |
| 1-50042-413 | In distribution | |
| 1-50043-111 | In distribution | |
| 1-10013-411 | In distribution | |
| 1-51031-005 | In distribution | |
| 1-50042-511 | In distribution | |
| 1-10013-163 | In distribution | |
| 1-50085-000 | In distribution | |
| 1-10013-113 | In distribution | |
| 1-10013-561 | In distribution | |
| 1-10013-660 | In distribution | |
| 1-10013-410 | In distribution | |
| 1-50043-411 | In distribution | |
| 1-50024-005 | In distribution | |
| 1-50042-110 | In distribution | |
| 1-10012-100 | In distribution | |
| 1-10013-109 | In distribution | |
| 1-10012-200 | In distribution | |
| 1-50042-213 | In distribution | |
| 1-50081-002 | In distribution | |
| 1-50081-001 | In distribution | |
| 1-50110-000 | In distribution | |
| 1-50042-310 | In distribution | |
| 1-10013-611 | In distribution | |
| 1-50041-003 | In distribution | |
| 1-50100-455 | In distribution | |
| 1-51039-000 | In distribution | |
| 1-51040-003 | In distribution | |
| 1-50024-001 | In distribution | |
| 1-10013-412 | In distribution | |
| 1-10013-512 | In distribution | |
| 1-50043-210 | In distribution | |
| 1-51041-002 | In distribution | |
| 1-10013-159 | In distribution | |
| 1-50025-004 | In distribution | |
| 1-10003-700 | In distribution | |
| 1-10013-259 | In distribution | |
| 1-50041-005 | In distribution | |
| 1-10012-350 | In distribution | |
| 1-51038-000 | In distribution | |
| 1-50043-209 | In distribution | |
| 1-10013-309 | In distribution | |
| 1-10003-410 | In distribution | |
| 1-50043-510 | In distribution | |
| 1-50043-211 | In distribution | |
| 1-10013-209 | In distribution | |
| 1-50024-002 | In distribution | |
| 1-10012-400 | In distribution | |
| 1-50040-004 | In distribution | |
| 1-50025-002 | In distribution | |
| 1-50043-313 | In distribution | |
| 1-51065-000 | In distribution | |
| 1-10003-310 | In distribution | |
| 1-50043-413 | In distribution | |
| 1-10013-311 | In distribution | |
| 1-51027-001 | In distribution | |
| 1-50043-110 | In distribution | |
| 1-10003-500 | In distribution | |
| 1-51030-004 | In distribution | |
| 1-50043-513 | In distribution | |
| 1-10013-310 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Engage Partial Knee System | Engage Uni, LLC | 385 |
| Restoris PST | Mako Surgical Corp. | 10 |
| Natural-Knee® | Zimmer, Inc. | 8 |
| Mako | Mako Surgical Corp. | 6 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222653 | 2022-10-28 |
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 |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 1994 units |
| Smith & Nephew, Inc. | 510(k) number | 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 1596 units |
| Smith & Nephew, Inc. | 510(k) number | 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 2146 units |
| Smith & Nephew, Inc. | 510(k) number | 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 7531 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.