Cleared Special

COLOR BUFFED (CB) DDH FEMORAL STEM (K012019) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012019 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
22d
Days
Class 2
Risk

K012019 is an FDA 510(k) clearance for the COLOR BUFFED (CB) DDH FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K012019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date July 20, 2001
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K012019.
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · DePuy Orthopaedics, Inc. · Dec 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · DePuy Orthopaedics, Inc. · Nov 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · Exactech, Inc. · Aug 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · Biomet, Inc. · Jul 2001
TRIDENT ALL POLY CUP
K012026 · Howmedica Osteonics Corp. · Jul 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · DePuy Orthopaedics, Inc. · Jun 2001