Cleared Traditional

(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT (K861723) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K861723 · Osteonics Corp. · Orthopedic device
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Jun 1986
Decision
34d
Days
Class 3
Risk

K861723 is an FDA 510(k) clearance for the (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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. High regulatory complexity profile. 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 Osteonics Corp. devices

Submission Details

510(k) Number K861723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date June 09, 1986
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K861723.
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · DePuy Orthopaedics, Inc. · Aug 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · Biomet, Inc. · May 2000
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · Osteonics Corp. · Jun 1985
ZIMMER THREADED ACETABULAR CUP
K850766 · Zimmer, Inc. · May 1985
PROFILE FEMORAL HIP
K850055 · Depuy, Inc. · Apr 1985