510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811630Substantially Equivalent

Kinematic Rotating Hinge Total Knee Pr.

Howmedica Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811630 is the FDA 510(k) clearance record for KINEMATIC ROTATING HINGE TOTAL KNEE PR., a class II device, cleared for Howmedica Corp. on under FDA product code LGE (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K811630.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LGE

Trailing 12 months

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

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