Cleared Traditional

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (K925536) - FDA 510(k) Clearance

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

K925536 · Orthomet, Inc. · Orthopedic device
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Jan 1994
Decision
431d
Days
Class 2
Risk

K925536 is an FDA 510(k) clearance for the HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 K925536 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 02, 1992
Decision Date January 07, 1994
Days to Decision 431 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 122d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 48
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K925536.
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · Johnson & Johnson Professionals, Inc. · Apr 1995
P.F.C. TOTAL HIP SYSTEM
K944132 · Johnson & Johnson Professionals, Inc. · Jan 1995
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
LEINBACH HIP PROSTHESIS
K896257 · 3M Company · Jan 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · 3M Company · Jan 1990