Home / 510(k) Clearances / K211553

510(k) K211553

Tecomet Global Unite Short Stem Instrumentation by Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. — Product Code PHX

K211553 is an FDA 510(k) premarket notification submitted by Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. for the device "Tecomet Global Unite Short Stem Instrumentation". The FDA issued a decision of Substantially Equivalent on Aug 4, 2021. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 4, 2021
Date Received
May 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Prosthesis, Reverse Configuration
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type
510(k)

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 grossly rotator cuff deficient joint.

Other clearances for product code PHX

  • K260556 — Veritas Shoulder System (Jul 1, 2026)
  • K261683 — Augment Off-Axis Instrument System (Jun 16, 2026)
  • K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid… (Jun 12, 2026)
  • K261016 — MSS - Humeral reverse liners extension (Jun 10, 2026)
  • K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (Apr 15, 2026)
  • K260583 — Equinoxe® Shoulder System (Apr 14, 2026)
  • K254128 — InSet Reverse Total Shoulder System (Apr 13, 2026)
  • K253674 — Blueprint Patient-Specific Instrumentation (Apr 3, 2026)
  • K253624 — INHANCE™ Reverse Shoulder System (Mar 11, 2026)

FDA data resources