Cleared Traditional

K874635 - OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES

K874635 is an FDA 510(k) clearance for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K874635 · Osteonics Corp. · Orthopedic device
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Mar 1988
Decision
121d
Days
Class 2
Risk

K874635 is an FDA 510(k) clearance for the OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 10, 1988 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 888.3560 - 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 - K874635

510(k) Number K874635 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 10, 1987
Decision Date March 10, 1988
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.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 893
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K874635.
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · Johnson & Johnson Professionals, Inc. · Oct 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · Howmedica Corp. · Oct 1988
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · Howmedica Corp. · Jul 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · Orthomet, Inc. · Feb 1988
INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM
K873602 · Intermedics Orthopedics · Jan 1988
KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
K874547 · Kirschner Medical Corp. · Dec 1987