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Device Explorer · FDA GUDID · GMDN 46479

Surgical implant template, reusable

A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut met

US‑registered devices12,113in commercial distribution
Companies141labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Signature Orthopaedics Pty Ltd1,40712%
Biomet Orthopedics, Llc1,1329%
4Web Medical9238%
Smith & Nephew, Inc.8447%
Nexus Spine, L.L.C.4524%
Synthes Gmbh4324%
Stryker Gmbh4264%
Encore Medical, L.P.3673%

Top labelers

CompanyDevicesShare
Signature Orthopaedics Pty Ltd1,40712%
Biomet Orthopedics, Llc1,1329%
4Web Medical9238%
Smith & Nephew, Inc.8447%
Nexus Spine, L.L.C.4524%
Synthes Gmbh4324%
Stryker Gmbh4264%
Encore Medical, L.P.3673%
Tornier3073%
Medtronic Sofamor Danek, Inc.3073%
Paragon 28, Inc.2542%
Depuy (Ireland)2362%

Company = labeler of record on GUDID. 141 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VARIAXINSTRUMENTPROMonterey ALOASYSES2 SPINAL SYSTEMXIA 4.5XIARESTORISREUNIONAXSOSANCHORAGENAX-FUSET2MEDPOR

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

FDA product codes

CodeNameDevices
HWTTEMPLATE4,570
HWTTemplate3,189
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM779
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT725
LXHOrthopedic manual surgical instrument668
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN647

GMDN & GCC registration

  • GMDN code 46479 · non‑implantable
  • Single‑use 2% · sterile 1% · 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

Height (Millimeter) · 861Length (Millimeter) · 656Width (Millimeter) · 529Outer Diameter (Millimeter) · 314Angle (degree) · 105Depth (Millimeter) · 35

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

How many surgical implant template, reusable products are registered in the US?

12,113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical implant template, reusable", from 141 companies. The largest labeler is Signature Orthopaedics Pty Ltd with 12% of records.

Which FDA product codes apply?

HWT (TEMPLATE), HWT (Template), 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.

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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