Cleared Traditional

K884410 - OMNIFIT TOTAL KNEE SERIES III

K884410 is the FDA 510(k) clearance for OMNIFIT TOTAL KNEE SERIES III by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K884410 · Osteonics Corp. · Orthopedic device
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Jan 1989
Decision
90d
Days
Class 2
Risk

K884410 is an FDA 510(k) clearance for the OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM. 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 January 18, 1989 after a review of 90 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

Submission Details

510(k) Number K884410 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 20, 1988
Decision Date January 18, 1989
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K884410.
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · Johnson & Johnson Professionals, Inc. · Mar 1989
CONTINUUM KNEE SYSTEM (CKS)
K882322 · Buckman Co., Inc. · Feb 1989
LACEY POSTERIOR STABILIZED KNEE SYSTEM
K884338 · Dow Corning Wright · Feb 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
K884398 · Osteonics Corp. · Jan 1989
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · Depuy, Inc. · Dec 1988
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · Kirschner Medical Corp. · Nov 1988