Cleared Traditional

K954186 - SLED UNICOMPARTMENT KNEE SYSTEM

K954186 is an FDA 510(k) clearance for SLED UNICOMPARTMENT KNEE SYSTEM, manufactured by Link America, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 142-day FDA review.

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

FDA 510(k) Submission Details - K954186

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
Combination Product No
PCCP Authorized No
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.

HSX Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K954186.
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · Sulzer Orthopedics, Inc. · Sep 2001
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K010685 · Zimmer, Inc. · Apr 2001
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
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