510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021549Substantially Equivalent

Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System

Std Mfg., Inc., Stoughton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021549 is the FDA 510(k) clearance record for CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM, a class II device, cleared for Std Mfg., Inc. on under FDA product code KXA (Prosthesis, Hip, Femoral, Resurfacing). FDA records list 6 510(k) clearances for Std Mfg., Inc., from to . As of , FDA records show no recalls naming K021549.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KXA Prosthesis, Hip, Femoral, Resurfacing
Regulation
21 CFR 888.3400
Device class
Class II
Review panel
Orthopedic
Applicant
Std Mfg., Inc. 1063 Tpke. St., Stoughton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXA

Trailing 12 months

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

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