Consulting Wallah › Device Explorer › Orthopaedic implants › Knee tibia prosthesis trial, reusable
Device Explorer · FDA GUDID · GMDN 58716

Knee tibia prosthesis trial, reusable

A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes

US‑registered devices19,428in commercial distribution
Companies33labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Smith & Nephew, Inc.3,03816%
Zimmer, Inc.1,93510%
Depuy (Ireland)1,8139%
Ortho Development Corporation1,7519%
Biomet Orthopedics, Llc1,7419%
Howmedica Osteonics Corp.1,6869%
Corentec Co., Ltd1,6809%
United Orthopedic Corp.8815%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.3,03816%
Zimmer, Inc.1,93510%
Depuy (Ireland)1,8139%
Ortho Development Corporation1,7519%
Biomet Orthopedics, Llc1,7419%
Howmedica Osteonics Corp.1,6869%
Corentec Co., Ltd1,6809%
United Orthopedic Corp.8815%
Exactech, Inc.8765%
Waldemar Link Gmbh & Co. Kg5683%
Limacorporate Spa5163%
Omni Life Science, Inc.4762%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InstrumentINSTRUMENTUnity Total Knee SystemRotaglide+ Modular Knee System with Fixed MeniscUniglide Unicondylar Knee ProsthesisOxford Partial Knee SystemVANGUARD(TM) PROVISIONALVANGUARD M SERIES KNEEVanguard M Series KneeAGC Knee SystemVANGUARD M UNICOMPARTMENTAL KNEEVANGUARD M KNEE SYSTEMUSTAR II Knee SystemU2 Total Knee SystemU2™ KneeU2 Knee Modular Disposable Trial

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

FDA product codes

CodeNameDevices
HWTTEMPLATE6,423
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem3,771
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM3,738
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,724
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN1,824
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 1,584

GMDN & GCC registration

  • GMDN code 58716 · non‑implantable
  • Single‑use 2% · sterile 1% · 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

Height (Millimeter) · 2,812Length (Millimeter) · 306Outer Diameter (Millimeter) · 217Width (Millimeter) · 57Angle (degree) · 35

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

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

19,428 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee tibia prosthesis trial, reusable", from 33 companies. The largest labeler is Smith & Nephew, Inc. with 16% of records.

Which FDA product codes apply?

HWT (TEMPLATE), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), 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.

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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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