Cleared Traditional

K944752 - ORTHOMET RESURFACING FEMORAL COMPONENT

K944752 is an FDA 510(k) clearance for ORTHOMET RESURFACING FEMORAL COMPONENT, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K944752 · Orthomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
93d
Days
Class 2
Risk

K944752 is an FDA 510(k) clearance for the ORTHOMET RESURFACING FEMORAL COMPONENT. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - 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. Standard predicate reliance. 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K944752

510(k) Number K944752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date December 28, 1994
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXA Device Classification - Class 2, Special Controls

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
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 - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K944752.
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · Corin USA · Feb 2000
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
MODUILAR UNIPOLAR
K950998 · Intermedics Orthopedics · Apr 1995
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604 · Biopro, Inc. · Nov 1989
BIPOLAR HIP SYSTEM
K892398 · Orthomet, Inc. · May 1989
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · Waldemar Link GmbH & Co. KG · Dec 1979