510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252516Substantially Equivalent

N22 EZ Glenosphere

SHOULDER INNOVATIONS, Inc, Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252516 is the FDA 510(k) clearance record for N22 EZ Glenosphere, a class II device, cleared for Shoulder Innovations, Inc. on under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration). FDA's definition for product code PHX reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a...". FDA records list 11 510(k) clearances for Shoulder Innovations, Inc., from to . As of , FDA records show no recalls naming K252516.

Clearance record

Decision date
Received
(157 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Shoulder Innovations, Inc. 1535 Steele Ave. SW, Grand Rapids MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHX

Trailing 12 months
16 clearances under product code PHX in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code PHX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20265
February 20261
March 20261
April 20264
May 20261
June 20263
July 20261
August 20260
September 20260
October 20260