510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001957Substantially Equivalent

Modular Rotating Hinge Knee Tibial Rotating Component

Howmedica Osteonics Corp, Rutherford NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001957 is the FDA 510(k) clearance record for MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT, a class II device, cleared for Howmedica Osteonics Corp. on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show no recalls naming K001957.

Clearance record

Decision date
Received
(28 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
Howmedica Osteonics Corp. 359 Veterans Blvd., Rutherford NJ
510(k) summary
Summary
Third party review
No

Clearances, product code KRO

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