Cleared Traditional

METAL ACETABULAR COMPONENT (K964227) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964227 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
83d
Days
Class 2
Risk

K964227 is an FDA 510(k) clearance for the METAL ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 14, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K964227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date January 14, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K964227.
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · Howmedica Corp. · Mar 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · Zimmer, Inc. · Feb 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · Osteonics Corp. · Jan 1997
APEX HOLE ELIMINATOR PS
K963309 · Depuy, Inc. · Nov 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · Depuy, Inc. · Oct 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186 · Depuy, Inc. · Sep 1996