GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

• 2 recalls, same reason

  • Ongoing Z-2410-2024 FDA Class II ·initiated 22 May 2024
  • Ongoing Z-2411-2024 FDA Class II ·initiated 22 May 2024

  Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

• 16 recalls, same reason

  • Ongoing Z-1543-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1549-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1551-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1552-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1540-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1548-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1550-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1553-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1554-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1545-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1541-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1544-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1547-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1542-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1539-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742
  • Ongoing Z-1546-2023 FDA Class II ·initiated 21 Mar 2023 ·on shared 510(k) K212742

  Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

• 4 recalls, same reason

  • Ongoing Z-1380-2022 FDA Class II ·initiated 24 May 2022
  • Ongoing Z-1377-2022 FDA Class II ·initiated 24 May 2022
  • Ongoing Z-1379-2022 FDA Class II ·initiated 24 May 2022
  • Ongoing Z-1378-2022 FDA Class II ·initiated 24 May 2022

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Gemini SL

Generic Name

Uncoated knee femur prosthesis, metallic

Model / Ref / Catalog

318-102/02, Femoral component, cemented, CoCrMo, fixed bearing CR / mobile bearing, Tibial component, TiCaP coating, uncemented, fixed bearing, modular, 318-377/03

Primary DI / UDI-DI

04026575311316, 04026575372997

Basic UDI-DI

4026575-1-KNP-200001-U2, 4026575-1-KNP-200012-UA

510(k) Number

K212742 ↗ 510(k)

K182872 ↗ GUDID

FDA Product Code

JWH

EMDN Code

P0909030101, P090903020105

GMDN Term

Uncoated knee femur prosthesis, metallic

Device Class

Class III EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3560

Market of Registration

Germany

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• MP Reconstruction System 134-518/12

  Class I

  GUDID on market

• General Instrument 15-8380/02B

  Class I

  GUDID on market

• MP Reconstruction System 134-518/13

  Class I

  GUDID on market

• MP Reconstruction System 134-518/14

  Class I

  GUDID on market

• MP Reconstruction System 134-518/15

  Class I

  GUDID on market

• MP Reconstruction System 134-518/16

  Class I

  GUDID on market

See all devices from WALDEMAR LINK GmbH & Co. KG →

• What types of knee surgeries is the GEMINI SL Total Knee System designed for, and how does its modularity benefit patients?

  The GEMINI SL Total Knee System is designed for total knee arthroplasty, including both primary and revision surgeries. Its modular components allow for customization to fit individual anatomical needs, ensuring better alignment and function. This adaptability supports patients with severe degenerative joint diseases like arthrosis or arthritis, providing tailored structural support and improved mobility.

• Is the GEMINI SL Total Knee System reusable, or is it intended for single-use in the operating room?

  The GEMINI SL Total Knee System is explicitly sterile and intended for single-use in surgical settings. This aligns with standard orthopedic implant protocols to ensure patient safety and sterility during procedures.

• What special coating does the GEMINI SL system feature, and why is it included?

  The system includes the LINK PorEx (TiNbN) inhouse coating, which is applied to enhance biocompatibility and osseointegration—meaning it promotes better bone attachment to the implant. This coating also helps reduce wear, improving long-term performance and durability for patients.

• How are the components of the GEMINI SL system sized, and can they be used with other LINK knee implants?

  The components come in predefined sizes to match anatomical requirements, ensuring proper fit and function. They are designed to be compatible with the broader LINK SL Knee Family concept, allowing seamless integration with other implants in the same system for consistent surgical planning.

• What regulatory pathways does the GEMINI SL Total Knee System follow, and what does that mean for its use in the U.S. and EU?

  The system follows FDA 510(k) clearance (K212742) under a Special 510(k) pathway, classified as FDA Class II, and complies with the EU Medical Device Regulation (MDR). This means it has undergone regulatory review for safety and effectiveness in both markets, ensuring it meets stringent standards for orthopedic implants.