# K211553: Tecomet Global Unite Short Stem Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
- Decided: Aug 4, 2021 after 77 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911686 (1991). 73 ancestors in all.
No later device cites it as a predicate yet.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170748: GLOBAL UNITE Platform Shoulder System, Depuy Ireland UC (2018) Summary page 4.
- K192855: DELTA XTEND (TM) Reverse Shoulder System, Depuy (Ireland) (2020) Summary page 4.

## Indications for use
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.

Source page: https://510kreport.com/device/K211553
Methodology: https://510kreport.com/methodology