Cleared Traditional

K962646 - PRIME MODULAR ENDO HEAD

K962646 is an FDA 510(k) clearance for PRIME MODULAR ENDO HEAD, manufactured by Orthopaedic Innovations, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962646 · Orthopaedic Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
77d
Days
Class 2
Risk

K962646 is an FDA 510(k) clearance for the PRIME MODULAR ENDO HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Orthopaedic Innovations, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopaedic Innovations, Inc. devices

FDA 510(k) Submission Details - K962646

510(k) Number K962646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date September 23, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 90
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K962646.
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · Encore Orthopedics, Inc. · Dec 1997
ULTIMA TPS CEMENTED STEM
K965198 · Johnson & Johnson International · Jul 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156 · Johnson & Johnson Professionals, Inc. · Jan 1997
OPTEON UNIPOLAR
K960538 · Exactech, Inc. · Mar 1996
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385 · Johnson & Johnson Professionals, Inc. · Jan 1996
OSTEONICS UNIPOLAR ENDO HEAD
K954534 · Osteonics Corp. · Nov 1995