510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K140547Substantially Equivalent

Excera Fitrite Total Hip Arthroplasty System

Excera Orthopedics, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140547 is the FDA 510(k) clearance record for EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM, a class II device, cleared for Excera Orthopedics, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 2 510(k) clearances for Excera Orthopedics, Inc., from to . As of , FDA records show no recalls naming K140547.

Clearance record

Decision date
Received
(324 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Excera Orthopedics, Inc. 80 Shelton Technology Center, Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260