Cleared Traditional

DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS (K970241) - FDA 510(k) Clearance

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

K970241 · Depuy, Inc. · Orthopedic device
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Aug 1997
Decision
204d
Days
Class 2
Risk

K970241 is an FDA 510(k) clearance for the DEPUY PROXIMAL FEMORAL REPLACEMENT 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 August 14, 1997 after a review of 204 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 K970241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1997
Decision Date August 14, 1997
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 K970241.
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · Howmedica Corp. · Nov 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · Depuy, Inc. · Nov 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · Howmedica Corp. · Jul 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · Wrightmedicaltechnologyinc · Jul 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · Depuy, Inc. · Jun 1997