Cleared Traditional

K925536 - HYBRID FEMORAL STEM

K925536 is an FDA 510(k) clearance for HYBRID FEMORAL STEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 431-day FDA review.

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

FDA 510(k) Submission Details - K925536

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
Combination Product No
PCCP Authorized No
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.

KWY Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K925536.
IOI COCR UNIPOLAR PROSTHESIS
K934159 · Intermedics Orthopedics · Jul 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994
TECHMEDICA STANDARD CEMENTED HIP SYSTEM
K926387 · Techmedica, Inc. · Feb 1994
TECHMEDICA STANDARD BIPOLAR SYSTEM
K925420 · Techmedica, Inc. · Sep 1993
CONSENSUS(TM) BIPOLAR SYSTEM
K922560 · U.S. Medical Products, Inc. · Sep 1992
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM
K913632 · Kirschner Medical Corp. · Nov 1991