Cleared Traditional

K963309 - APEX HOLE ELIMINATOR PS

K963309 is an FDA 510(k) clearance for APEX HOLE ELIMINATOR PS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K963309 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
82d
Days
Class 2
Risk

K963309 is an FDA 510(k) clearance for the APEX HOLE ELIMINATOR PS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 12, 1996 after a review of 82 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K963309

510(k) Number K963309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1996
Decision Date November 12, 1996
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K963309.
METAL BACKED ACETABULAR COMPONENT
K963998 · Encore Orthopedics, Inc. · Jan 1997
MAYO HIP PROSTHESIS
K943230 · Mayo Clinic · Jan 1997
METAL ACETABULAR COMPONENT
K964227 · Encore Orthopedics, Inc. · Jan 1997
NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
K963266 · Intermedics Orthopedics · Oct 1996
HORIZON HIP SYSTEM
K962769 · Biologically Oriented Prostheses · Oct 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · Depuy, Inc. · Oct 1996