510(k) K261683

Augment Off-Axis Instrument System by Zimmer, Inc. — Product Code PHX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 16, 2026
Date Received: May 21, 2026
Clearance Type: Special
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

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 by Zimmer, Inc.

K260831 — Z1 Hip System (June 16, 2026)
K251840 — Zimmer® Persona® Personalized Knee System (May 28, 2026)
K260182 — Avenir® Müller Stem; Avenir Complete Hip System (April 27, 2026)
K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity H (April 13, 2026)
K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
K252623 — G7® Revision Acetabular System (February 4, 2026)
K251098 — Identity Revision Humeral Stems (August 11, 2025)
K251906 — Z1 Hip System (July 18, 2025)
K250848 — Identity Shoulder System (July 2, 2025)

Other clearances for product code PHX

K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid (June 12, 2026)
K261016 — MSS - Humeral reverse liners extension (June 10, 2026)
K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
K260583 — Equinoxe® Shoulder System (April 14, 2026)
K254128 — InSet Reverse Total Shoulder System (April 13, 2026)
K253674 — Blueprint Patient-Specific Instrumentation (April 3, 2026)
K253624 — INHANCE Reverse Shoulder System (March 11, 2026)
K250644 — MSS - Monobloc stem (February 3, 2026)
K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)