510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781971Substantially Equivalent

Knee System, Quadraxial Constrained

Hexcel Medical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781971 is the FDA 510(k) clearance record for KNEE SYSTEM, QUADRAXIAL CONSTRAINED, a class II device, cleared for Hexcel Medical on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list 13 510(k) clearances for Hexcel Medical, from to . As of , FDA records show no recalls naming K781971.

Clearance record

Decision date
Received
(128 days to decision)
Product code
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3510
Device class
Class II
Review panel
Orthopedic
Applicant
Hexcel Medical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRO

Trailing 12 months
2 clearances under product code KRO in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260