510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802124Substantially Equivalent

Gristina Glenoid Prosthesis

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

K802124 is the FDA 510(k) clearance record for GRISTINA GLENOID PROSTHESIS, a class II device, cleared for Howmedica Corp. on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K802124.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3650
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KWT

Trailing 12 months
2 clearances under product code KWT 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 KWT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260