Cleared Traditional

K910807 - KEANE UNI KNEE SYSTEM

K910807 is an FDA 510(k) clearance for KEANE UNI KNEE SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K910807 · Depuy, Inc. · Orthopedic device
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Jun 1991
Decision
121d
Days
Class 2
Risk

K910807 is an FDA 510(k) clearance for the KEANE UNI KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 27, 1991 after a review of 121 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K910807

510(k) Number K910807 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 26, 1991
Decision Date June 27, 1991
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K910807.
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
K915240 · Intermedics Orthopedics · Jan 1992
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
K912735 · Smith & Nephew Richards, Inc. · Dec 1991
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
K914439 · Johnson & Johnson Orthopaedics, Inc. · Oct 1991
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