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510(k) K192206

Device
32mm Glenosphere And Humeral Cup
Applicant
FX Shoulder USA, Inc.
510(k) number
K192206
Product code
PHX  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-08
Date received
2019-08-14
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
No

Applicant Contact#

Contact
Kathy Trier
Address
13465 Midway Rd. Suite 101 Dallas TX US 75244 75244

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
K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.2026-04-13
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

Legacy Summary#

summary

FDA Review#

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