Cleared Traditional

K003758 - ALLOFIT ACETABULAR SYSTEM

K003758 is an FDA 510(k) clearance for ALLOFIT ACETABULAR SYSTEM, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K003758 · Sulzer Orthopedics, Inc. · Orthopedic device
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Mar 2001
Decision
91d
Days
Class 3
Risk

K003758 is an FDA 510(k) clearance for the ALLOFIT ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 7, 2001 after a review of 91 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K003758

510(k) Number K003758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date March 07, 2001
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KWA Device Classification - Class 3, Premarket Approval

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 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K003758.
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · DePuy Orthopaedics, Inc. · Dec 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · Wrightmedicaltechnologyinc · Jul 2002
M2A ACETABULAR SYSTEM
K011110 · Biomet, Inc. · Jul 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · Encore Orthopedics, Inc. · Jan 2001
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · DePuy Orthopaedics, Inc. · Dec 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883 · DePuy Orthopaedics, Inc. · Oct 2000