Cleared Traditional

SLED UNICOMPARTMENT KNEE SYSTEM (K954186) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954186 · Link America, Inc. · Orthopedic device
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Jan 1996
Decision
142d
Days
Class 2
Risk

K954186 is an FDA 510(k) clearance for the SLED UNICOMPARTMENT KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Link America, Inc. (East Hanavor, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Link America, Inc. devices

Submission Details

510(k) Number K954186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date January 26, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 Peers - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 70
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K954186.
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K992287 · Howmedica Osteonics Corp. · Nov 1999
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES
K952068 · Zimmer, Inc. · Sep 1995
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
K942263 · Zimmer, Inc. · Jul 1995
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
K945613 · Howmedica Corp. · Mar 1995