Consulting Wallah › Device Explorer › Orthopaedic implants › Knee stem prosthesis trial
Device Explorer · FDA GUDID · GMDN 64799

Knee stem prosthesis trial

A copy of a final femur or tibia stem prosthesis designed to be used during knee arthroplasty (TKA) to determine the correct size of the final prosthesis. Also referred to as a nail trial, it is one of a set, or a set, of graduated sizes and is typically made

US‑registered devices104in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Total Joint Orthopedics, Inc.8986%
Merete Gmbh1212%
Link Bio Corp33%

Top labelers

CompanyDevicesShare
Total Joint Orthopedics, Inc.8986%
Merete Gmbh1212%
Link Bio Corp33%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OsteoBridge™Femur Trial/Stem Trial AdapterStem TrialLinkBio Instrument

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

FDA product codes

CodeNameDevices
LXHOrthopedic manual surgical instrument89
HWTTEMPLATE12
HWTTemplate3

GMDN & GCC registration

  • GMDN code 64799 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 88% · 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

No structured size data on the register.

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

How many knee stem prosthesis trial products are registered in the US?

104 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee stem prosthesis trial", from 3 companies. The largest labeler is Total Joint Orthopedics, Inc. with 86% of records.

Which FDA product codes apply?

LXH (Orthopedic manual surgical instrument), HWT (TEMPLATE), HWT (Template)

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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