GMK Revision Knee SC Liners

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K103170 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Medacta International S.A. →

• Are the GMK Revision Knee SC Liners designed for primary knee replacements, or are they specifically for revision surgeries?

  These liners are exclusively intended for revision total knee arthroplasty, not primary procedures. Their design addresses ligament instability and bone defects common in complex knee replacements, ensuring secure fixation and anatomical alignment for patients undergoing repeat surgeries. The term *revision* in the name and description confirms their specialized use.

• How are the GMK Revision Knee SC Liners supplied, and what does that mean for surgical workflow?

  They are supplied as single-use, sterile devices, meaning each liner is packaged for one procedure and cannot be reused. This eliminates the need for sterilization between cases, simplifying workflow and reducing contamination risks. The sterile packaging ensures readiness for immediate use in revision surgeries.

• What types of fixation do these liners support, and how does that affect their use in revision knee procedures?

  The liners are intended for cemented fixation, meaning they are secured to the bone using orthopedic cement during surgery. This method is critical in revision cases, where bone quality may be compromised, as cement provides additional stability to the implant. The design ensures compatibility with Medacta’s revision protocols, which rely on cemented components for reliability.

• Are these liners compatible with other knee systems, or are they part of a proprietary Medacta revision platform?

  While the liners are engineered to comply with orthopedic revision standards, their primary compatibility is with Medacta’s existing knee systems and revision protocols. The design is tailored for Medacta’s revision scenarios, ensuring seamless integration with their established surgical techniques and implant components. Third-party systems would require validation.

• How do I determine the correct size or configuration for a patient’s revision knee surgery?

  Sizing and configuration are tailored for complex revision scenarios, requiring surgical precision during placement. The liners are not one-size-fits-all; their design accounts for variable bone defects and ligament instability in repeat knee replacements. Surgeons must follow Medacta’s revision protocols and use intraoperative assessment to select the appropriate liner for the patient’s anatomy and defect characteristics.