Cleared Traditional

K994207 - HOWMEDICA OSTEONICS MODULAR ROTATING HI...

K994207 is the FDA 510(k) clearance for HOWMEDICA OSTEONICS MODULAR ROTATING HI... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K994207 · Howmedica Osteonics Corp. · Orthopedic device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994207 is an FDA 510(k) clearance for the HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 13, 2000 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 888.3510 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K994207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date March 13, 2000
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 70
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K994207.
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · Howmedica Osteonics Corp. · Nov 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · Howmedica Osteonics Corp. · Jul 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · Howmedica Osteonics Corp. · Jun 2000
HINGED KNEE
K982160 · Encore Orthopedics, Inc. · Mar 1999
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · Howmedica Corp. · Jul 1998
FINN KNEE SYSTEM
K945028 · Biomet, Inc. · Feb 1996