Cleared Traditional

ORTHOMET ACETABULAR CUP SYSTEM (K931333) - FDA 510(k) Clearance

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

K931333 · Orthomet, Inc. · Orthopedic device
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Oct 1994
Decision
577d
Days
Class 2
Risk

K931333 is an FDA 510(k) clearance for the ORTHOMET ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 577 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Orthomet, Inc. devices

Submission Details

510(k) Number K931333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date October 14, 1994
Days to Decision 577 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 122d · This submission: 577d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K931333.
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301 · Depuy, Inc. · Apr 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · Zimmer, Inc. · Mar 1995
APOGEE HIP STEM WITH POROCOAT
K934334 · Depuy, Inc. · Dec 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · Osteonics Corp. · Oct 1994
PRECISION OSTELOCK SP FEMORAL COMPONENT
K941141 · Howmedica Corp. · Sep 1994
INFINITY REVISION HIP STEM
K942115 · Wrightmedicaltechnologyinc · Sep 1994