Cleared Special

K212742 - GEMINI SL Total Knee System

K212742 is the FDA 510(k) clearance for GEMINI SL Total Knee System by Waldemar Link GmbH & Co. KG. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 17-day FDA review.

K212742 · Waldemar Link GmbH & Co. KG · Orthopedic device
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Sep 2021
Decision
17d
Days
Class 2
Risk

K212742 is an FDA 510(k) clearance for the GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System wit.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on September 16, 2021 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Waldemar Link GmbH & Co. KG devices

Submission Details

510(k) Number K212742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2021
Decision Date September 16, 2021
Days to Decision 17 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

LinkBio Corp.
Terry Sheridan Powell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

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