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Device Explorer · FDA GUDID · GMDN 33705

Total wrist prosthesis

A sterile implantable artificial substitute for a wrist joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes radial and carpal components, usually with an intervening bal

US‑registered devices245in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.10442%
Ascension Orthopedics, Inc.10442%
Stryker Gmbh229%
Extremity Medical, Llc146%
Vyaire Medical, Inc.10%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.10442%
Ascension Orthopedics, Inc.10442%
Stryker Gmbh229%
Extremity Medical, Llc146%
Vyaire Medical, Inc.10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REMOTIONUniversal2 Total Wrist Implant SystemFreedom Wrist Arthroplasty SystemKinematXIntegra® Freedom Wrist Arthroplasty SystemUniversal 2™ Total Wrist SystemLTV

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, 127
JWJProsthesis, wrist, 3 part metal-plastic-metal articulation, 104
JWJPROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, 23
CBKVentilator, continuous, facility use1

GMDN & GCC registration

  • GMDN code 33705 · implantable
  • Single‑use 100% · sterile 96% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 33

Use these as the dimensions to specify in a tender line.

How many total wrist prosthesis products are registered in the US?

245 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total wrist prosthesis", from 5 companies. The largest labeler is Smith & Nephew, Inc. with 42% of records.

Which FDA product codes apply?

JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, ), JWJ (Prosthesis, wrist, 3 part metal-plastic-metal articulation, ), JWJ (PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, ), CBK (Ventilator, continuous, facility use)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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