510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163497Substantially Equivalent

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt

Encore Medical, LP, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163497 is the FDA 510(k) clearance record for EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt, a class II device, cleared for Encore Medical L.P. on under FDA product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer). FDA records list 85 510(k) clearances for Encore Medical L.P., from to . As of , FDA records show one recall naming K163497.

Clearance record

Decision date
Received
(79 days to decision)
Product code
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Regulation
21 CFR 888.3310
Device class
Class II
Review panel
Orthopedic
Applicant
Encore Medical L.P. 9800 Metric Blvd., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWZ

Trailing 12 months

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

FDA records show no clearances under product code KWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWZ, 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