Cleared Traditional

K932923 - IMPLEX A-230 POROUS ACETABULAR CUP SYST...

K932923 is the FDA 510(k) clearance for IMPLEX A-230 POROUS ACETABULAR CUP SYST... by Implex Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K932923 · Implex Corp. · Orthopedic device
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May 1994
Decision
322d
Days
Class 2
Risk

K932923 is an FDA 510(k) clearance for the IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on May 3, 1994 after a review of 322 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 Implex Corp. devices

Submission Details

510(k) Number K932923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1993
Decision Date May 03, 1994
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
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 424
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K932923.
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102 · Howmedica Corp. · May 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924 · Implex Corp. · May 1994
REFLECTION ACETABULAR COMPONENT
K932755 · Smith & Nephew Richards, Inc. · May 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642 · Smith & Nephew Richards, Inc. · Apr 1994
TRILOGY ACETABULAR SYSTEM
K934765 · Zimmer, Inc. · Apr 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994