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FDA 510(k)

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

K-Number: K252352 · 2026-01-22

ApplicantLima Corporate S.P.A.
Decision Date2026-01-22
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252352. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K252352.

When did SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System receive FDA 510(k) clearance?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252352.

Who is the listed applicant for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is PHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITINGNCT06371833PRIMA EU Retrospective & ProspectiveRECRUITING

Other records listing Lima Corporate S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251718ArTT Augments and Buttresses and Bone ScrewsK243826SMR Reverse HP Shoulder SystemK250980Physica System (Physica CR Porous Femoral components)K243615Physica Porous Femoral ComponentsK234011AMF TT ConesK233712PRIMA Humeral System; PRIMA TT Glenoid

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Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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