Cleared Traditional

K910083 - OMNIFIT TOTAL KNEE BONE AUGMENTATION WE...

K910083 is the FDA 510(k) clearance for OMNIFIT TOTAL KNEE BONE AUGMENTATION WE... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K910083 · Osteonics Corp. · Orthopedic device
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Apr 1991
Decision
83d
Days
Class 2
Risk

K910083 is an FDA 510(k) clearance for the OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteonics Corp. devices

Submission Details

510(k) Number K910083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1991
Decision Date April 01, 1991
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K910083.
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K915240 · Intermedics Orthopedics · Jan 1992
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KEANE UNI KNEE SYSTEM
K910807 · Depuy, Inc. · Jun 1991
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
K903286 · Techmedica, Inc. · Oct 1990
CAAS UNICOMPARMENTAL KNEE SYSTEM
K900619 · Techmedica, Inc. · Jun 1990
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
K896648 · Concept, Inc. · Jun 1990