Cleared Traditional

K862837 - OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

K862837 is an FDA 510(k) clearance for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K862837

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.

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 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