Cleared Special

K993569 - APR METASUL ACETABULAR INSERT

K993569 is an FDA 510(k) clearance for APR METASUL ACETABULAR INSERT, manufactured by Sulzermedica. The device is a Class 3 Orthopedic device with product code KWA cleared through the Special 510(k) pathway after a 41-day FDA review.

K993569 · Sulzermedica · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
41d
Days
Class 3
Risk

K993569 is an FDA 510(k) clearance for the APR METASUL ACETABULAR INSERT. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Sulzermedica (Austin, US). The FDA issued a Cleared decision on December 1, 1999 after a review of 41 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 Sulzermedica devices

FDA 510(k) Submission Details - K993569

510(k) Number K993569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1999
Decision Date December 01, 1999
Days to Decision 41 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 103
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K993569.
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · DePuy Orthopaedics, Inc. · Aug 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · Sulzer Orthopedics, Inc. · Jul 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · Biomet, Inc. · May 2000
INTER-OP METASUL ACETABULAR SYSTEM
K974728 · Sulzer Orthopedics, Inc. · Aug 1999
THOMPSON TYPE HIP PROTHESIS
K922868 · Osteo Technology, Inc. · Feb 1993
MODIFIED FREEMAN ACETABULAR CUP
K902110 · Turnkey Intergration USA, Inc. · Aug 1990