Consulting Wallah › Device Explorer › Orthopaedic implants › Ankle prosthesis trial, reusable
Device Explorer · FDA GUDID · GMDN 61863

Ankle prosthesis trial, reusable

A copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically ma

US‑registered devices1,234in commercial distribution
Companies8labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Wright Medical Technology, Inc.37731%
Ascension Orthopedics, Inc.26121%
Smith & Nephew, Inc.25020%
Exactech, Inc.22218%
Vilex Llc464%
Dt Medtech, Llc423%
Zimmer, Inc.302%
Trilliant Surgical, Llc60%

Top labelers

CompanyDevicesShare
Wright Medical Technology, Inc.37731%
Ascension Orthopedics, Inc.26121%
Smith & Nephew, Inc.25020%
Exactech, Inc.22218%
Vilex Llc464%
Dt Medtech, Llc423%
Zimmer, Inc.302%
Trilliant Surgical, Llc60%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Incompass Total Ankle SystemMade-To-OrderINFINITY™ ADAPTIS™INVISIONINBONEINFINITYTrabecular Metal®Cadence Total Ankle SystemXT Revision Ankle Replacement SystemSalto Talaris Total Ankle ProsthesisHintermann Series3S HemiVantageVantage®, Activit-ECADENCE®Salto Talaris®

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

FDA product codes

CodeNameDevices
HWTTEMPLATE798
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER215
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT108
LXHOrthopedic manual surgical instrument75
LXHOrthopedic Manual Surgical Instrument51
LHXTrousers, anti-shock18

GMDN & GCC registration

  • GMDN code 61863 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 97% · 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

Height (Millimeter) · 292Outer Diameter (Millimeter) · 10

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

How many ankle prosthesis trial, reusable products are registered in the US?

1,234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ankle prosthesis trial, reusable", from 8 companies. The largest labeler is Wright Medical Technology, Inc. with 31% of records.

Which FDA product codes apply?

HWT (TEMPLATE), HSN (PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument)

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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