Cleared Traditional

K950761 - INDEX ACETABULAT COMPONENT

K950761 is the FDA 510(k) clearance for INDEX ACETABULAT COMPONENT by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K950761 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
74d
Days
Class 2
Risk

K950761 is an FDA 510(k) clearance for the INDEX ACETABULAT COMPONENT. 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 May 2, 1995 after a review of 74 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. 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 Biomet, Inc. devices

Submission Details

510(k) Number K950761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1995
Decision Date May 02, 1995
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K950761.
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
K943696 · Depuy, Inc. · May 1995
ALPHA SYSTEM
K950312 · Zimmer, Inc. · May 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · Biomet, Inc. · May 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · Zimmer, Inc. · Apr 1995
PROVIDENT HP SYSTEM
K946371 · Stelkast Company · Apr 1995
FOUNDATION NON-POROUS STEM
K935449 · Encore Orthopedics, Inc. · Mar 1995