Anatomical Shoulder System— 510(k) K193099

Clearance details

Applicant

Zimmer GmbH

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2019-11-07

Decision date

2020-01-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Winterthur, CH

• K260556 — Veritas Shoulder System2026-07-01
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
• K261016 — MSS - Humeral reverse liners extension2026-06-10
• K253992 — Veritas Reverse Total Shoulder System2026-05-07

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K200112 — Zimmer Hip Joint Replacement2020-04-10
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26
• K193030 — Avenir Muller Stem, Avenir Cemented Hip Stem2019-12-06

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 →