Consulting Wallah › Device Explorer › Orthopaedic implants › Total wrist carpal articulation prosthesis
Device Explorer · FDA GUDID · GMDN 35663

Total wrist carpal articulation prosthesis

An implantable device designed to replace some of the carpal bone articulating surfaces as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). It is made of metal [e.g., titanium (Ti), cobalt-ch

US‑registered devices85in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc6273%
Wright Medical Technology, Inc.2327%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc6273%
Wright Medical Technology, Inc.2327%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Maestro™ Total WristMAESTRO TOTAL WRISTSWANSONTIE-INORTHOSPHERE

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, 62
KYIPROSTHESIS, WRIST, CARPAL TRAPEZIUM12
KWNPROSTHESIS, WRIST, CARPAL LUNATE11
KWOPROSTHESIS, WRIST, CARPAL SCAPHOID6
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL6

GMDN & GCC registration

  • GMDN code 35663 · implantable
  • Single‑use 100% · sterile 100% · 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

Outer Diameter (Millimeter) · 6

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

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

85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total wrist carpal articulation prosthesis", from 2 companies. The largest labeler is Biomet Orthopedics, Llc with 73% of records.

Which FDA product codes apply?

JWJ (PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, ), KYI (PROSTHESIS, WRIST, CARPAL TRAPEZIUM), KWN (PROSTHESIS, WRIST, CARPAL LUNATE), KWO (PROSTHESIS, WRIST, CARPAL SCAPHOID)

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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