Cleared Traditional

K896648 - CONCEPT UNICOMPARTMENTAL KNEE SYSTEM

K896648 is an FDA 510(k) clearance for CONCEPT UNICOMPARTMENTAL KNEE SYSTEM, manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

FDA 510(k) Submission Details - K896648

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
Combination Product No
PCCP Authorized No
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.

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 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K896648.
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K910083 · Osteonics Corp. · Apr 1991
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
K903286 · Techmedica, Inc. · Oct 1990
CAAS UNICOMPARMENTAL KNEE SYSTEM
K900619 · Techmedica, Inc. · Jun 1990
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · Osteonics Corp. · Feb 1990
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
K894068 · Kirschner Medical Corp. · Dec 1989
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
K881779 · Dow Corning Wright · Aug 1988