Cleared Traditional

K862837 - OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

K862837 is the FDA 510(k) clearance for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM by Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K862837 · Osteonics Corp. · Orthopedic device
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Dec 1986
Decision
150d
Days
Class 2
Risk

K862837 is an FDA 510(k) clearance for the OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM. 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 December 22, 1986 after a review of 150 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 Osteonics Corp. devices

Submission Details

510(k) Number K862837 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 25, 1986
Decision Date December 22, 1986
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
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 K862837.
KIRSCHNER UNICONDYLAR KNEE SYSTEM
K873970 · Kirschner Medical Corp. · Dec 1987
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
K872735 · Howmedica Corp. · Aug 1987
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · Zimmer, Inc. · Mar 1987
WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
K861715 · Dow Corning Wright · Jul 1986
MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE
K862136 · Dow Corning Wright · Jul 1986
TRICON UNICOMPARTMENTAL KNEE SYSTEM
K854325 · Richards Medical Co., Inc. · Dec 1985