Cleared Traditional

K933102 - HOWMEDICA ACETABULAR SHELL W/SCREW HOLES

K933102 is an FDA 510(k) clearance for HOWMEDICA ACETABULAR SHELL W/SCREW HOLES, 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 326-day FDA review.

K933102 · Howmedica Corp. · Orthopedic device
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May 1994
Decision
326d
Days
Class 2
Risk

K933102 is an FDA 510(k) clearance for the HOWMEDICA ACETABULAR SHELL W/SCREW HOLES. 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 May 16, 1994 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K933102

510(k) Number K933102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1993
Decision Date May 16, 1994
Days to Decision 326 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 122d · This submission: 326d
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 K933102.
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K934412 · Joint Medical Products Corp. · Jun 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924 · Implex Corp. · May 1994
REFLECTION ACETABULAR COMPONENT
K932755 · Smith & Nephew Richards, Inc. · May 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923 · Implex Corp. · May 1994