Gemini SL Total Knee System
The Gemini SL Total Knee System replaces the three articular portions of the knee with a semi-constrained prosthesis. Its indications include disabling arthritic disease, femoral-condyle…
The Gemini SL Total Knee System replaces the three articular portions of the knee with a semi-constrained prosthesis. Its indications include disabling arthritic disease, femoral-condyle avascular necrosis, post-traumatic joint damage and moderate deformity, with cemented fixation of the main components.
Cruciate-retaining and posterior-stabilised configurations are available. The retaining version requires an intact posterior cruciate ligament, while the stabilised version provides mechanical coupling when that ligament is absent. Both combine femoral and tibial metal components with polyethylene bearing surfaces.
Component Fixation
The tibial baseplate can accept modular stems. Only stems specifically labelled for cementless use are intended for uncemented fixation; the knee components otherwise retain the cemented-use indication.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K182872 |
| Record published | 2023-01-25 |
| Record revised | 2025-06-09 (version 2) |
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, expiry date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 318-472/02 | In distribution | |
| 318-472/04 | In distribution | |
| 318-002/00 | In distribution | |
| 318-473/01 | In distribution | |
| 318-473/02 | In distribution | |
| 318-001/00 | In distribution | |
| 318-473/05 | In distribution | |
| 318-472/01 | In distribution | |
| 318-473/03 | In distribution | |
| 318-472/05 | In distribution | |
| 318-473/04 | In distribution | |
| 318-472/03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230471 | 2023-03-21 |
| K212742 | 2021-09-16 |
| K202924 | 2021-05-13 |
| K191755 | 2019-07-18 |
| K182872 | 2019-04-03 |
Recalls
16 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-07-31 | Class II | Under Investigation by firm | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. | 8 units |
| 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 1180 units |
| 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 908 units |
| 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 441 units |
| 2025-04-03 | Class II | Nonconforming Material/Component | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | 1771 units |
| 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 37 units |
| 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 20 units |
| 2025-02-14 | Class II | Labeling Change Control | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | 52 units |
| 2024-05-22 | Class II | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique | 114 units US; 2351 units OUS |
| 2024-05-22 | Class II | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique | 552 units; 7351 units OUS |
| 2022-12-23 | Class II | Component change control | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). | 20 units |
| 2022-12-23 | Class II | Component change control | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). | 20 units |
| 2022-05-24 | Class II | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. | 3785 |
| 2022-05-24 | Class II | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. | 3785 |
| 2022-05-24 | Class II | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. | 3785 |
| 2022-05-24 | Class II | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. | 3785 |
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.