Cleared Traditional

INFINITY POROUS-COATED TROCHANTERIC MODULE (K922159) - FDA 510(k) Clearance

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

K922159 · Wrightmedicaltechnologyinc · Orthopedic device
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Oct 1993
Decision
526d
Days
Class 2
Risk

K922159 is an FDA 510(k) clearance for the INFINITY POROUS-COATED TROCHANTERIC MODULE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 526 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K922159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date October 15, 1993
Days to Decision 526 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 122d · This submission: 526d
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 K922159.
METALLIC TOATAL HIP SYSTEM
K921274 · Biomet, Inc. · Feb 1994
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · Exactech, Inc. · Oct 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · Exactech, Inc. · Oct 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · Biomet, Inc. · Jul 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201 · Osteonics Corp. · Jun 1993
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · Zimmer, Inc. · Jul 1992