510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043346Substantially Equivalent

Genesis Total Shoulder Replacement, Model 100-01-00

Genesis Medical LLC, Cranbury NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043346 is the FDA 510(k) clearance record for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00, a class II device, cleared for Genesis Medical LLC on under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). FDA records list 2 510(k) clearances for Genesis Medical LLC, from to . As of , FDA records show no recalls naming K043346.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Genesis Medical LLC 2650 Us Hwy. 130, Cranbury NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWS

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