Cleared Special

K003391 - OSTEONICS ALUMINA C-TAPER HEAD

K003391 is the FDA 510(k) clearance for OSTEONICS ALUMINA C-TAPER HEAD by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 28-day FDA review.

K003391 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
28d
Days
Class 2
Risk

K003391 is an FDA 510(k) clearance for the OSTEONICS ALUMINA C-TAPER HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 28, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K003391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date November 28, 2000
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K003391.
LPC-PLUS ACETABULAR CUP
K003274 · Plus Orthopedics · Apr 2001
PORTRAIT FEMORAL COMPONENT
K010560 · Biomet, Inc. · Mar 2001
V-40/C-TAPER ADAPTER SLEEVE
K003379 · Howmedica Osteonics Corp. · Nov 2000
ALUMINA V40 HEAD
K003413 · Howmedica Osteonics Corp. · Nov 2000
ACCOLADE C FEMORAL COMPONENT
K002320 · Howmedica Osteonics Corp. · Sep 2000
FENNING HIP STEM
K002441 · DePuy Orthopaedics, Inc. · Sep 2000