Skip to content

PRIMA Humeral System and SMR Glenosphere Ø42

by Lima Corporate S.P.A.

510(k) K212800

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212800 Date25 Feb 2022ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2024-2025 FDA Class II initiated 19 May 2025
    • Ongoing Z-2025-2025 FDA Class II initiated 19 May 2025

    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Prima Humeral System and SMR Glenosphere Ø42 is a modular shoulder arthroplasty device designed for primary or revision total or partial shoulder replacement. It includes humeral stems, bodies, adaptors, heads, reverse trays, and inserts, configured for either anatomic or reverse shoulder arthroplasty. The Ø42 Glenosphere component is part of a reverse configuration system, enabling mechanical articulation for improved shoulder function. This device is classified under the product code PHX as a Shoulder Prosthesis, Reverse Configuration.

The system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. It requires mechanical assembly by a surgeon based on patient anatomy and clinical needs. The device has received FDA 510(k) clearance under K212800, adhering to Class II – Special Controls for orthopedic implants. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

Other devices from Lima Corporate S.P.A.

See all devices from Lima Corporate S.P.A. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Prima Humeral System Ø42 Glenosphere used for?

    The Prima Humeral System Ø42 Glenosphere is designed for primary or revision total or partial shoulder replacement, including both anatomic and reverse shoulder arthroplasty. The Ø42 Glenosphere component is specifically part of a reverse configuration system, enabling mechanical articulation to restore shoulder function in complex cases where natural anatomy is compromised.

  • How is the Prima Humeral System supplied and prepared for use?

    The system is supplied as a sterile, single-use device. It requires mechanical assembly by a surgeon in the operating room, tailored to the patient’s anatomy and clinical needs. The modular components—humeral stems, bodies, adaptors, heads, reverse trays, and inserts—must be assembled according to the manufacturer’s instructions to ensure proper fit and function.

  • Is the Prima Humeral System reusable or intended for single-use?

    The Prima Humeral System is explicitly intended for single-use only. This classification aligns with standard sterile medical device protocols to prevent cross-contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer.

  • What storage and handling precautions must be followed for this device?

    The device must be stored and handled according to sterile medical device protocols to maintain its integrity before use. This includes keeping it in its original packaging until sterilization verification is confirmed, protecting it from physical damage, and adhering to expiration dates or sterility indicators provided by the manufacturer.

  • Does the Prima Humeral System include components for both anatomic and reverse shoulder replacements?

    Yes, the Prima Humeral System is designed as a modular platform that accommodates both anatomic and reverse shoulder arthroplasty configurations. The Ø42 Glenosphere is specifically part of the reverse configuration system, while other components (such as humeral stems and anatomic heads) are used for traditional shoulder replacements. The surgeon selects and assembles the appropriate components based on the surgical plan.