Consulting Wallah › Device Explorer › Orthopaedic implants › Wrist ulna-head prosthesis
Device Explorer · FDA GUDID · GMDN 33720

Wrist ulna-head prosthesis

A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a o

US‑registered devices112in commercial distribution
Companies5labelers on GUDID
Single‑use99%of device records
Sterile82%labelled sterile
Prescription77%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.2623%
Aptis Medical, Llc2623%
Ascension Orthopedics, Inc.2421%
Stryker Gmbh2119%
Kapp Surgical Instrument Co.1513%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.2623%
Aptis Medical, Llc2623%
Ascension Orthopedics, Inc.2421%
Stryker Gmbh2119%
Kapp Surgical Instrument Co.1513%

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

Brand names on the register (sample)

NAUHEADFirst Choice Partial Ulnar Head ImplantFirst Choice Modular Ulnar Head ImplantBioMotion Cannulated 1st MPJ Hemi SystemSeitz Solution Unlar HeadScheker ProsthesisAscension® First Choice® DRUJ System

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

FDA product codes

CodeNameDevices
KXEProsthesis, Wrist, Hemi-, Ulnar53
KXEPROSTHESIS, WRIST, HEMI-, ULNAR45
KXEProsthesis, wrist, hemi-, ulnar21
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL5

GMDN & GCC registration

  • GMDN code 33720 · implantable
  • Single‑use 99% · sterile 82% · Rx‑only 77% · 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) · 9Length (Millimeter) · 5Width (Millimeter) · 3

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

No closely related category with 50+ devices.

How many wrist ulna-head prosthesis products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wrist ulna-head prosthesis", from 5 companies. The largest labeler is Smith & Nephew, Inc. with 23% of records.

Which FDA product codes apply?

KXE (Prosthesis, Wrist, Hemi-, Ulnar), KXE (PROSTHESIS, WRIST, HEMI-, ULNAR), KXE (Prosthesis, wrist, hemi-, ulnar), KWD (PROSTHESIS, TOE, HEMI-, PHALANGEAL)

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.

How do I get quotes?

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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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