Cleared Traditional

CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (K896648) - FDA 510(k) Clearance

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

K896648 · Concept, Inc. · Orthopedic device
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Jun 1990
Decision
193d
Days
Class 2
Risk

K896648 is an FDA 510(k) clearance for the CONCEPT UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Concept, Inc. (Largo, US). The FDA issued a Cleared decision on June 5, 1990 after a review of 193 days - an extended review cycle.

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 Concept, Inc. devices

Submission Details

510(k) Number K896648 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 24, 1989
Decision Date June 05, 1990
Days to Decision 193 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 122d · This submission: 193d
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 K896648.
KEANE UNI KNEE SYSTEM WITH POROCOAT
K921232 · Depuy, Inc. · Jun 1992
KEANE UNI KNEE SYSTEM
K910807 · Depuy, Inc. · Jun 1991
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K910083 · Osteonics Corp. · Apr 1991
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · Osteonics Corp. · Feb 1990
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
K880155 · Zimmer, Inc. · Aug 1988
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
K872735 · Howmedica Corp. · Aug 1987