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FDA PRODUCT CODE · CLASS II

PHX — Shoulder Prosthesis, Reverse Configuration

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3660
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
27
510(K)/PMA CLEARANCES
510k: 27
0
RECALL ENTRIES

Recent clearances

K260556Restor3D · 510k2026-07-01
K261683Zimmer, Inc. · 510k2026-06-16
K260102Stryker Corporation (Tornier, Inc.) · 510k2026-06-12
K261016Medacta International, SA · 510k2026-06-10
K253992Restor3D · 510k2026-05-07
K252404Biomet Orthopedics · 510k2026-04-15
K260583Exactech, Inc. · 510k2026-04-14
K254128Shoulder Innovations, Inc. · 510k2026-04-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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