Cleared Traditional

S.A.F. ACETABULAR CUP (K895157) - FDA 510(k) Clearance

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

K895157 · Synergy Orthopaedics Intl., Inc. · Orthopedic device
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Dec 1989
Decision
113d
Days
Class 3
Risk

K895157 is an FDA 510(k) clearance for the S.A.F. ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Synergy Orthopaedics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 113 days - within the typical 510(k) review window.

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 Synergy Orthopaedics Intl., Inc. devices

Submission Details

510(k) Number K895157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1989
Decision Date December 01, 1989
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 122d · This submission: 113d
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 58
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K895157.
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K002379 · Biomet, Inc. · Aug 2000
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
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · Osteonics Corp. · Jun 1986
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · Osteonics Corp. · Jun 1985