Cleared Special

COLOR BUFFED ANSWER CEMENTED FEMORAL (K991987) - FDA 510(k) Clearance

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

K991987 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
14d
Days
Class 2
Risk

K991987 is an FDA 510(k) clearance for the COLOR BUFFED ANSWER CEMENTED FEMORAL. 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 June 28, 1999 after a review of 14 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 K991987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date June 28, 1999
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 K991987.
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · Biomet, Inc. · Feb 2000
COLOR BUFFED CEMENTED FEMORAL
K992903 · Biomet, Inc. · Sep 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · Biomet, Inc. · Jul 1999
SYNERGY CEMENTED HIP STEM
K990369 · Smith & Nephew, Inc. · Mar 1999
MODULAR PROTUSIO CUP
K990032 · Biomet, Inc. · Feb 1999
APF POROUS COATED LINE EXTENSION
K984154 · Biomet, Inc. · Feb 1999