510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K211553Substantially Equivalent

Tecomet Global Unite Short Stem Instrumentation

Symmetry Medical Manufacturing Inc. dba Tecomet, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211553 is the FDA 510(k) clearance record for Tecomet Global Unite Short Stem Instrumentation, a class II device, cleared for Symmetry Medical Manufacturing Inc. Dba Tecomet, 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 one 510(k) clearance for Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. As of , FDA records show no recalls naming K211553.

Clearance record

Decision date
Received
(77 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. 3724 N. State Rd. 15, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHX

Trailing 12 months
17 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 20261