Orthopedic · 510(k) · 2026
Veritas Reverse Total Shoulder System
Restor3D. Cleared by FDA on 7 May 2026 under submission K253992, product code PHX (shoulder prosthesis, reverse configuration). What FDA's record says, in FDA's words.
Device record · K253992
- Device. Veritas Reverse Total Shoulder SystemDEVICE
- Company. Restor3DCOMPANY
- Decision. 7 May 2026, 510(k), substantially equivalent (traditional review); received 12 December 2025DECISION
- Panel. OrthopedicPANEL
- Product code. PHX, Shoulder Prosthesis, Reverse ConfigurationCODE
- Regulation. 21 CFR 888.3660, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This 1<253992 ? textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Veritas Reverse Total Shoulder System Please provide your Indications for Use below. ? The Veritas Reverse Total Shoulder System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants, and a functional deltoid muscle is necessary. The Veritas Reverse Total Shoulder System standard components are indicated for primary, fracture and revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The system's patient specific components are only indicated for primary total shoulder replacement. Glenoid components with porous surface are indicated for uncemented application with the addition of screw fixation. Humeral components with porous surface are indicated for either cemented or uncemented applications. Note: A CT scan is used to create the Veritas TM patient specific components. Please select the types of uses (select one or both, as !X] Prescription Use (21 CFR 801 Subpart 0) applicable). D Over-The-Counter Use (21 CFR 801 Subpart C) ? 40 01 NC-54 Hwy Suite 3160 Durham, NC 27709 Veritas […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 13,256 reports filed against devices carrying product code PHX. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · SMR Shoulder · Limacorporate S.p.A · report 3008021110-2026-00361
Revision surgery has been performed on(b)(6) 2026 due to instability resulting in dislocation of the shoulder prosthesis.Patient has humeral bone losse and needed to have a larger glenosphere to help with stability.Patient underwent prior revision for cuff failure on (b)(6) 2025 (Mfr. 3008021110-2025-00047) and was converted from an anatomical to a reverse configuration.During current revision the pre-existing assembly consisting of:SMR REVERSE HUMERAL BODY (code 1352.15.010, lot 2434590 […]
30 September 2026 · Injury · Shoulder System · Medacta International SA · report 3005180920-2026-00980
The patient had primary right shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain due to a malpositioned baseplate and the cause of the malpositioned baseplate is unknown. The surgeon revised the baseplate, glenosphere and liner. The surgery was completed successfully. (b)(4).On (b)(6) 2026, the patient came in reporting pain due to a loose baseplate due to poor bone quality. The surgeon revised the baseplate, the glenosphere and the liner. The surgery was […]
30 September 2026 · Injury · HUMERIS · FX SHOULDER SOLUTIONS · report 3009532798-2026-00050
The patient was revised due to dislocation on (b)(6) 2026.The implantation date was on (b)(6) 2017. A glenosphere and a humeral cup were explanted. A glenosphere and a humeral cup were implanted .
30 September 2026 · Malfunction · COMPR METAL IMPACTOR · Zimmer Biomet, Inc. · report 0001825034-2026-02918
It was reported that an impactor tip broke. Attempts have been made and no further information has been provided.
30 September 2026 · Injury · Comprehensive Reverse Shoulder Glenosphere · Zimmer Biomet, Inc. · report 0001825034-2026-02919
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PHX, in Orthopedic, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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