FDA.reportPublic FDA data

510(k) K254128

Device
InSet Reverse Total Shoulder System
Applicant
Shoulder Innovations, Inc.
510(k) number
K254128
Product code
PHX
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-13
Date received
2025-12-22
Regulation
888.3660
Classification name
Shoulder Prosthesis, Reverse Configuration
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Mark D. Hanes
Address
1535 Steele Ave. SW Suite B Grand Rapids MI US 49507 49507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260556Veritas Shoulder SystemRestor3D2026-07-01
K261683Augment Off-Axis Instrument SystemZimmer, Inc.2026-06-16
K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)2026-06-12
K261016MSS - Humeral reverse liners extensionMedacta International, SA2026-06-10
K253992Veritas Reverse Total Shoulder SystemRestor3D2026-05-07
K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics2026-04-15
K260583Equinoxe® Shoulder SystemExactech, Inc.2026-04-14
K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)2026-04-03
K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2026-03-11
K250644MSS - Monobloc stemMedacta International S.A.2026-02-03
K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.2026-01-22
K252516N22 EZ GlenosphereShoulder Innovations, Inc.2026-01-15
K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.2026-01-15
K254003JARVIS Metaphyseal StemFH Industrie2026-01-09
K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.2026-01-08