510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003758Substantially Equivalent

Allofit Acetabular System

Sulzer Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003758 is the FDA 510(k) clearance record for ALLOFIT ACETABULAR SYSTEM, a class III device, cleared for Sulzer Orthopedics, Inc. on under FDA product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)). FDA records list 45 510(k) clearances for Sulzer Orthopedics, Inc., from to . As of , FDA records show no recalls naming K003758.

Clearance record

Decision date
Received
(91 days to decision)
Product code
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation
21 CFR 888.3330
Device class
Class III
Review panel
Orthopedic
Applicant
Sulzer Orthopedics, Inc. 9900 Spectrum Dr., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code KWA

Trailing 12 months

FDA records hold no clearances under product code KWA in the trailing twelve months.

FDA records show no clearances under product code KWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260