510(k) K260102
- Device
- Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
- Applicant
- Stryker Corporation (Tornier, Inc.)
- 510(k) number
- K260102
- Product code
- PHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2026-01-13
- 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
- Jang Long
- Address
- 10801 Nesbitt Ave. S. Bloomington MN US 55437 55437
FDA Registration Numbers#
- 3014302784
- 3006001176
- 1424263
- 3010314800
- 1422572
- 3005130928
- 1043534
- 3035366890
- 3007420745
- 3012470322
- 9617840
- 1825034
- 3015806723
- 3012818475
- 3003403260
- 3015207155
- 3010009693
- 3009971621
- 3005180920
- 3007051929
- 3010178296
- 3013791180
- 3009532798
- 3012552981
- 3006356043
- 3006563559
- 1054811
- 3013086329
- 9616944
- 3008102042
- 3000264985
- 3000258338
- 3014680795
- 3002807295
- 1043653
- 3005913274
- 2249697
- 3008395353
- 3014004349
- 2183946
- 1000200989
- 3008812251
- 3013014058
- 1649390
- 1220246
- 3010287737
- 3013176080
- 3010375065
- 3004748528
- 3008868758
- 3008337808
- 3015542154
- 3004641308
- 3009923578
- 3000931034
- 9681465
- 1833506
- 1835572
- 3025603301
- 9615674
- 3005562917
- 1000517406
- 3014315560
- 1018470
- 1526534
- 3002807310
- 3009887475
- 3013561205
- 3009555447
- 3009732568
- 3009185591
- 3002579136
- 3013194153
- 1721676
- 3027484613
- 1836116
- 3003387384
- 3002806470
- 3033273230
- 3010173425
Source Documents#
Other 510(k) Records For Product Code PHX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260556 | Veritas Shoulder System | Restor3D | 2026-07-01 |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026-06-16 |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | 2026-06-10 |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026-05-07 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026-04-14 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 |
| K253624 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2026-03-11 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026-01-22 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026-01-08 |