510(k) K243643

Device: restor3d Reverse Total Shoulder Arthroplasty System
Applicant: Restor3D
510(k) number: K243643
Product code: PHX
Decision: Substantially Equivalent (SESE)
Decision date: 2025-05-19
Date received: 2024-11-26
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
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: Brianna Prindle
Address: 4001 Nc-54 Hwy. Suite 2160 Durham NC US 27709 27709

FDA Registration Numbers

3003403260
1423662
1450662
1000200989
3027484613
1833506
1422572
3004641308
3005180920
2133928
3009241418
1649390
3013176080
3021008900
3010386387
1043534
3006801265
3008388276
1835831
3009941480
3009871135
1644408
2183946
1834331
3006721341
1018470
3011461101
3010287737
3000264985
3013194153
3013791180
3007420745
3014027736
1827096
3002579136
3015806723
3025603301
3005061536
3012818475
3010163695
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1043653
1219655
3029890418
3007740680
1721676
3015516266
3009475821
3009116370
3004976965
3004153896
3014680795
3013302242
3031914485
3007923096
3009423112
3013014058
9613350
3014262693
3000258338
2249697
3010331645
3012523063
3020967480
3008110533
3020704423
3015231789
3002907620
3033273230
3002808022
1649518
9681465
3010400367
3011015572
3005562917
1645151
3002807310
3011500362
3012470322
1835572
3007051929
3010047402
3009732568
3012552981
3014833750
3006001176
1526534
3002807295
3014004349
1828464
1038671
3005596372
3009888740
1825034
9617840
2245304
3009887475
9616680
1000517406
1834379
3009555440
3005497913
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3008102042
1220246
3009185591
3009555447
3009971621
2030624
3008534770
3004371426
3011724582
3013086329
8010916
3012544635
8010379
3010314800
3015207155
1221934
3009532798
3019269298
3004154314
3017397663
3006946276
3009923578
3014207283
1220477
3006017180
3008021110
1835444
3008337808
3019807891
2029275
1226544
1054811
3006356043
3005130928
3005913274
3003898228
3014315560
3002806470
3010009693
3008868758
3010178296
3003387384
3005718816
3035366890
3033509898
3010370880
3010173425
3036756245
3006563559
9616944
3008421730
2244478
8031020
3006272282
1822565
3004748528
1818910
3013055499
3013561205
3008812251
3002806603
1836116
3007441485
1020279
3011274144
3010065126
3011943495
2249615
3009546990
3008658204
9615674
3000931034
8043792
3008395353
1836357
3016851379
3014128390
1424263
3003998208
2528981
9616671
3010375065
1529009
3004983210
3006984710
3014302784

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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00840097534343	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515861	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515786	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515632	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515779	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515854	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515816	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515793	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097534336	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515939	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515892	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515878	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515922	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097534329	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515984	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515946	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515847	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515649	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515625	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515823	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515991	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515908	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515885	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515977	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515809	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515762	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515953	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515915	Veritas rTSA	Restor3d, Inc.	2025-08-25
00840097515830	Veritas rTSA	Restor3d, Inc.	2025-08-25

Other 510(k) Records For Product Code PHX

510(k)	Device	Applicant	Decision date
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
K250338	MSS - Humeral reverse liners extension	Medacta International S.A.	2025-10-31
K253345	JARVIS Diaphyseal Stem Standard	FH Industrie	2025-10-29
K252221	Inset Reverse Total Shoulder System	Shoulder Innovations, Inc.	2025-09-26