Cleared Traditional

TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS (K964650) - FDA 510(k) Clearance

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

K964650 · Depuy, Inc. · Orthopedic device
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Jun 1997
Decision
211d
Days
Class 2
Risk

K964650 is an FDA 510(k) clearance for the TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS. 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 June 19, 1997 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K964650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date June 19, 1997
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K964650.
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · Depuy, Inc. · Aug 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · Howmedica Corp. · Jul 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · Wrightmedicaltechnologyinc · Jul 1997
PEGGED ACETABULAR COMPONENT
K970501 · Biomet, Inc. · Apr 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · Howmedica Corp. · Mar 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · Zimmer, Inc. · Feb 1997