Lateralized Glenosphere

FDA 510(k) K193175 · Medacta Inernational SA

Substantially Equivalent

510(k) numberK193175

Submission

Device name
Lateralized Glenosphere
Applicant
Medacta Inernational SA
Castel San Pietro (Ch), CH
Received
November 18, 2019
Decision date
August 11, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PHX – Shoulder Prosthesis, Reverse Configuration
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Specialty
Orthopedic
Implant
Yes

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.

Other 510(k)s with product code PHX

510(k)DeviceApplicantDecision
K260556Veritas Shoulder SystemPHX · Traditional Restor3D07/01/2026SE
K261683Augment Off-Axis Instrument SystemPHX · Special Zimmer, Inc.06/16/2026SE
K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional Stryker Corporation (Tornier, Inc.)06/12/2026SE
K261016MSS - Humeral reverse liners extensionPHX · Traditional Medacta International, SA06/10/2026SE
K253992Veritas Reverse Total Shoulder SystemPHX · Traditional Restor3D05/07/2026SE
K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional Biomet Orthopedics04/15/2026SE
K260583Equinoxe® Shoulder SystemPHX · Traditional Exactech, Inc.04/14/2026SE
K254128InSet Reverse Total Shoulder SystemPHX · Traditional Shoulder Innovations, Inc.04/13/2026SE
K253674Blueprint Patient-Specific InstrumentationPHX · Traditional Stryker Corporation (Tornier, S.A.S.)04/03/2026SE
K253624INHANCE™ Reverse Shoulder SystemPHX · Traditional Depuy Ireland UC03/11/2026SE

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Questions and answers

When was Lateralized Glenosphere cleared by the FDA?

Lateralized Glenosphere (K193175) received a 510(k) decision of Substantially Equivalent on August 11, 2020, 267 days after the submission was received.

What is the product code of K193175?

The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.