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Device Explorer · FDA GUDID · GMDN 13180

Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves

US‑registered devices35,630in commercial distribution
Companies173labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Zimmer, Inc.4,79413%
Spinal Elements, Inc.3,70110%
Vb Spine Llc3,3419%
Encore Medical, L.P.2,9388%
Howmedica Osteonics Corp.2,8868%
Smith & Nephew, Inc.2,7728%
Biomet Orthopedics, Llc1,1063%
L&K Biomed Co. ,Ltd.9183%

Top labelers

CompanyDevicesShare
Zimmer, Inc.4,79413%
Spinal Elements, Inc.3,70110%
Vb Spine Llc3,3419%
Encore Medical, L.P.2,9388%
Howmedica Osteonics Corp.2,8868%
Smith & Nephew, Inc.2,7728%
Biomet Orthopedics, Llc1,1063%
L&K Biomed Co. ,Ltd.9183%
Fournitures Hospitalieres Industrie8652%
Spinal Elements8372%
Medtronic Sofamor Danek, Inc.7292%
Corin Ltd6932%

Company = labeler of record on GUDID. 173 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Patient-Fitted TMJ Reconstructive Prosthesis SysPANGEAHOFFMANN LRFREUNIONINSTRUMENTSPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 6SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 2SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 5SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 4SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 1SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 8SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 3SPECIALTY TRIATHLON TS CUTTING GUIDE SIZE 7InstrumentN/AAviator

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 Instrument8,557
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT7,194
LXHOrthopedic manual surgical instrument3,227
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM2,830
HWTTEMPLATE2,544
FZXGuide, surgical, instrument2,386

GMDN & GCC registration

  • GMDN code 13180 · non‑implantable
  • Single‑use 2% · sterile 1% · Rx‑only 81% · 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 (Millimeter) · 1,377Height (Millimeter) · 1,058Width (Millimeter) · 917Angle (degree) · 706Outer Diameter (Millimeter) · 626Depth (Millimeter) · 187

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

How many orthopaedic prosthesis implantation positioning instrument, reusable products are registered in the US?

35,630 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic prosthesis implantation positioning instrument, reusable", from 173 companies. The largest labeler is Zimmer, Inc. with 13% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM)

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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