Cleared Traditional

K935731 - ACETABULAR SHELL

K935731 is an FDA 510(k) clearance for ACETABULAR SHELL, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K935731 · Howmedica Corp. · Orthopedic device
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Mar 1994
Decision
92d
Days
Class 2
Risk

K935731 is an FDA 510(k) clearance for the ACETABULAR SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 3, 1994 after a review of 92 days - within the typical 510(k) review window.

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 Howmedica Corp. devices

FDA 510(k) Submission Details - K935731

510(k) Number K935731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date March 03, 1994
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 534
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K935731.
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994
POROCOAT POROUS COATING
K931641 · Depuy, Inc. · Mar 1994
REPLICA(TM) TOTAL HIP SYSTEM
K926156 · Osteo Technology, Inc. · Mar 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308 · Zimmer, Inc. · Feb 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557 · Zimmer, Inc. · Feb 1994
ZIMMER ANATOMIC HIP SYSTEM
K922071 · Zimmer, Inc. · Feb 1994