Engage Partial Knee System
Engage is a partial knee replacement system for the medial compartment. It combines a femoral component, tibial tray and tibial insert, with a tibial anchor for cementless tray fixation.…
Engage is a partial knee replacement system for the medial compartment. It combines a femoral component, tibial tray and tibial insert, with a tibial anchor for cementless tray fixation. The filed Affinium 3D coated tibial tray is one component of the system.
The tray and anchor are Ti-6Al-4V titanium alloy, the insert is UHMWPE, and the femoral component is cobalt-chromium-molybdenum alloy. All femoral sizes can pair with the available tibial tray and associated insert combinations.
Listed Item
Affinium 3D Coated Tibial Tray, Right Medial, Size 2
Fixation Surfaces
The tibial tray has pegs and an engineered porous surface; the femoral component has pegs and a sintered porous coating. These surfaces support biological fixation without cement or fixation with PMMA bone cement. The tibial anchor provides supplemental fixation only in the cementless tray configuration.
1manufacturer
385catalogue 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 | Engage Uni, LLC, 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 |
| 510(k) | K190439 |
| Record published | 2020-07-10 |
| Record revised | 2022-09-16 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-51014-030 | In distribution | |
| 1-50012-002-A | In distribution | |
| 1-51041-006 | In distribution | |
| 1-50000-000 | In distribution | |
| 1-51058-000 | In distribution | |
| 1-50062-000-A | In distribution | |
| 1-50010-001-A | In distribution | |
| 1-10011-100 | In distribution | |
| 1-10003-400 | In distribution | |
| 1-10011-200 | In distribution | |
| 1-50024-004 | In distribution | |
| 1-10013-161 | In distribution | |
| 1-51016-002-A | In distribution | |
| 1-51015-013-A | In distribution | |
| 1-51015-029 | In distribution | |
| 1-50011-003-A | In distribution | |
| 1-51067-000-A | In distribution | |
| 1-50010-002 | In distribution | |
| 1-51040-004-A | In distribution | |
| 1-10012-500 | In distribution | |
| 1-50003-000-A | In distribution | |
| 1-51015-013 | In distribution | |
| 1-51005-005 | In distribution | |
| 1-51055-011 | In distribution | |
| 1-51031-003 | In distribution | |
| 1-51016-101 | In distribution | |
| 1-51037-001 | In distribution | |
| 1-10013-463 | In distribution | |
| 1-51030-004 | In distribution | |
| 1-50020-000-A | In distribution | |
| 1-50011-011 | In distribution | |
| 1-50043-613 | In distribution | |
| 1-50077-010 | In distribution | |
| 1-51040-002-A | In distribution | |
| 1-50009-002 | In distribution | |
| 1-10013-559 | In distribution | |
| 1-50042-409 | In distribution | |
| 1-51041-002-A | In distribution | |
| 1-50042-413 | In distribution | |
| 1-51060-000-A | In distribution | |
| 1-50043-509 | In distribution | |
| 1-50041-004-A | In distribution | |
| 1-51004-000-A | In distribution | |
| 1-51036-001 | In distribution | |
| 1-50024-003 | In distribution | |
| 1-50001-000-A | In distribution | |
| 1-50010-003 | In distribution | |
| 1-50005-000 | In distribution | |
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| 1-51015-030-A | In distribution | |
| 1-51015-031-A | In distribution | |
| 1-51030-003 | In distribution | |
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| 1-51037-001-A | In distribution | |
| 1-10003-200 | In distribution | |
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| 1-51014-031 | In distribution | |
| 1-51040-005-A | In distribution | |
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| 1-51015-010 | In distribution | |
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| 1-50005-000-A | In distribution | |
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| 1-50040-002 | In distribution | |
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| 1-50041-002-A | In distribution | |
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| 1-10013-311 | In distribution | |
| 1-50042-209 | In distribution | |
| 1-51030-005 | In distribution | |
| 1-50043-409 | In distribution | |
| 1-50040-003 | In distribution | |
| 1-51030-002 | In distribution | |
| 1-50013-000 | In distribution | |
| 1-51015-011-A | In distribution | |
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| 1-51041-004-A | In distribution | |
| 1-50042-309 | In distribution | |
| 1-50011-001 | In distribution | |
| 1-51016-005 | In distribution | |
| 1-51005-000-A | In distribution | |
| 1-50043-411 | In distribution | |
| 1-10003-210 | In distribution | |
| 1-51040-005 | In distribution | |
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| 1-51035-000 | In distribution | |
| 1-50041-005 | In distribution | |
| 1-51016-004-A | In distribution | |
| 1-50040-004-A | In distribution | |
| 1-50012-001 | In distribution | |
| 1-51016-001-A | In distribution | |
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| 1-51041-007-A | In distribution | |
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| 1-50085-000 | In distribution | |
| 1-50040-005-A | In distribution | |
| 1-10012-450 | In distribution | |
| 1-50077-006 | In distribution | |
| 1-50040-006-A | In distribution | |
| 1-50040-003-A | In distribution | |
| 1-50009-002-A | In distribution | |
| 1-51016-101-A | In distribution | |
| 1-10003-310 | In distribution | |
| 1-50058-000 | In distribution | |
| 1-50024-001 | In distribution | |
| 1-50011-000-A | In distribution | |
| 1-51015-011 | In distribution | |
| 1-51059-000 | In distribution | |
| 1-51037-004 | In distribution | |
| 1-50010-000 | In distribution | |
| 1-50081-002 | In distribution | |
| 1-10013-513 | In distribution | |
| 1-51038-000 | In distribution | |
| 1-51016-103-A | In distribution | |
| 1-51041-004 | In distribution | |
| 1-50041-005-A | In distribution | |
| 1-10013-410 | In distribution | |
| 1-50041-006-A | In distribution | |
| 1-51016-005-A | In distribution | |
| 1-50008-001-A | In distribution | |
| 1-50012-002 | In distribution | |
| 1-50008-001 | In distribution | |
| 1-50042-411 | In distribution | |
| 1-50016-000 | In distribution | |
| 1-50011-002-A | In distribution | |
| 1-51015-031 | In distribution | |
| 1-51016-003 | In distribution | |
| 1-50043-211 | In distribution | |
| 1-10013-259 | In distribution | |
| 1-51041-007 | In distribution | |
| 1-50011-010 | In distribution | |
| 1-10013-613 | In distribution | |
| 1-50082-000 | In distribution | |
| 1-50042-611 | In distribution | |
| 1-10013-360 | In distribution | |
| 1-10013-510 | In distribution | |
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| 1-50000-000-A | In distribution | |
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| 1-50012-001-A | In distribution | |
| 1-50011-001-A | In distribution | |
| 1-51014-013-A | In distribution | |
| 1-51040-007 | In distribution | |
| 1-50042-410 | In distribution | |
| 1-10013-310 | In distribution | |
| 1-50009-001 | In distribution | |
| 1-50008-002-A | In distribution | |
| 1-50043-110 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Engage | Smith & Nephew, Inc. | 112 |
| Restoris PST | Mako Surgical Corp. | 10 |
| Natural-Knee® | Zimmer, Inc. | 8 |
| Mako | Mako Surgical Corp. | 6 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190439 | 2019-11-21 |
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.