GLOBAL UNITE Platform Shoulder System

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K212710 ↗

FDA Product Code

PHX

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from DePuy Ireland UC →

• What types of shoulder surgeries is the GLOBAL UNITE Platform Shoulder System designed for?

  The GLOBAL UNITE Platform Shoulder System is specifically designed for three primary shoulder arthroplasty procedures: anatomical shoulder replacements, reverse shoulder arthroplasties, and fracture shoulder reconstructions. Its modular design allows surgeons to select components tailored to each patient’s unique anatomical needs, ensuring versatility across these indications.

• Is the GLOBAL UNITE Platform Shoulder System intended for reuse, or is it single-use only?

  The GLOBAL UNITE Platform Shoulder System is explicitly supplied as a sterile, single-use orthopedic implant. This design ensures patient safety and maintains sterility protocols in surgical settings, preventing cross-contamination or degradation from repeated use.

• How should the GLOBAL UNITE Platform Shoulder System be stored to maintain its integrity?

  The system must be stored and handled according to sterile medical device protocols to preserve its integrity before surgical use. Since it is single-use and sterile upon packaging, it should remain in its original, unopened packaging in a clean, dry environment, protected from moisture, extreme temperatures, and physical damage.

• What regulatory pathways does the GLOBAL UNITE Platform Shoulder System follow, and how does that affect its use?

  The system is authorized under FDA 510(k) clearance (K212710) and MDR compliance, confirming it meets U.S. and EU regulatory standards for shoulder arthroplasty devices. This clearance indicates it is considered substantially equivalent to a predicate device, ensuring its safety and effectiveness for anatomical, reverse, and fracture shoulder procedures as described in the design.

• Does the modularity of the GLOBAL UNITE Platform Shoulder System affect how it’s selected for a patient?

  Yes, the modularity allows surgeons to customize the implant by choosing specific components for each patient’s anatomy—such as stem lengths, head sizes, or reverse configurations—ensuring a precise fit for anatomical, reverse, or fracture shoulder reconstructions. This adaptability streamlines surgical planning and improves outcomes by tailoring the prosthesis to individual needs.