Augment Off-Axis Instrument System— 510(k) K261683
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K261683 for Augment Off-Axis Instrument System, Substantially Equivalent on 2026-06-16. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's Augment Off-Axis Instrument System is filed under PHX, reverse-configuration shoulder prostheses. The name describes an instrument system while the code name is a prosthesis, and the record doesn't explain the fit.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It was a Special 510(k).
Zimmer filed from Warsaw, Indiana. The decision came 26 calendar days after receipt (May 21 to June 16, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code PHX
view allMore clearances from Zimmer, Inc.
view all- K262955 — OsseoFit Stemless Shoulder System
- K260831 — Z1 Hip System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.