Cleared Traditional

HINGED KNEE (K982160) - FDA 510(k) Clearance

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

K982160 · Encore Orthopedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
271d
Days
Class 2
Risk

K982160 is an FDA 510(k) clearance for the HINGED KNEE. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 17, 1999 after a review of 271 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K982160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1998
Decision Date March 17, 1999
Days to Decision 271 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 122d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 53
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K982160.
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · Howmedica Osteonics Corp. · Jul 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · Howmedica Osteonics Corp. · Jun 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · Howmedica Osteonics Corp. · Mar 2000
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · Howmedica Corp. · Jul 1998
FINN KNEE SYSTEM
K945028 · Biomet, Inc. · Feb 1996
FINN KNEE PROSTHESIS
K910877 · Biomet, Inc. · Jul 1991