510(k) K261683— Augment Off-Axis Instrument System

Substantially Equivalent

Zimmer, Inc.

Clearance details

Applicant: Zimmer, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2026-05-21
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.