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Device Explorer · FDA GUDID · GMDN 40124

Hinged total elbow prosthesis

A sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of me

US‑registered devices129in commercial distribution
Companies6labelers on GUDID
Single‑use98%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tornier, Inc.6047%
Zimmer, Inc.5744%
Wright Medical Technology, Inc.54%
Biomet Orthopedics, Llc32%
Encore Medical, L.P.22%
Limacorporate Spa22%

Top labelers

CompanyDevicesShare
Tornier, Inc.6047%
Zimmer, Inc.5744%
Wright Medical Technology, Inc.54%
Biomet Orthopedics, Llc32%
Encore Medical, L.P.22%
Limacorporate Spa22%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Coonrad/Morrey Total ElbowNAZimmer® Nexel® Total ElbowN/AZimmer® Nexel® Total Elbow Vivacit-E® Highly CroNexel™BI-AXIAL™ ELBOW SYSTEMDISCOVERY ELBOW SYSTEMLatitude™ - ElbowSORBIE QUESTOR ™SORBIE QUESTORDJO SURGICALTEMA Elbow

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

FDA product codes

CodeNameDevices
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED122
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED72
JDCProsthesis, Elbow, Constrained, Cemented3
JDBProsthesis, Elbow, Semi-Constrained, Cemented2

GMDN & GCC registration

  • GMDN code 40124 · implantable
  • Single‑use 98% · sterile 100% · Rx‑only 98% · 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 (Inch) · 25Length (Millimeter) · 12Outer Diameter (Millimeter) · 2

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

How many hinged total elbow prosthesis products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hinged total elbow prosthesis", from 6 companies. The largest labeler is Tornier, Inc. with 47% of records.

Which FDA product codes apply?

JDC (PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED), JDB (PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED), JDC (Prosthesis, Elbow, Constrained, Cemented), JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)

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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