Consulting Wallah › Device Explorer › Other devices › Orthopaedic implant aiming/guiding block, reusable
Device Explorer · FDA GUDID · GMDN 47815

Orthopaedic implant aiming/guiding block, reusable

A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) dur

US‑registered devices944in commercial distribution
Companies30labelers on GUDID
Single‑use4%of device records
Sterile3%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Wright Medical Technology, Inc.14515%
Biomet Orthopedics, Llc14415%
Signature Orthopaedics Pty Ltd14315%
Corin Ltd10511%
Smith & Nephew, Inc.849%
Zimmer, Inc.808%
Biomet Uk Ltd364%
Citieffe Srl303%

Top labelers

CompanyDevicesShare
Wright Medical Technology, Inc.14515%
Biomet Orthopedics, Llc14415%
Signature Orthopaedics Pty Ltd14315%
Corin Ltd10511%
Smith & Nephew, Inc.849%
Zimmer, Inc.808%
Biomet Uk Ltd364%
Citieffe Srl303%
Jeil Medical Corporation283%
Miami Device Solutions Llc253%
Implantcast Gmbh172%
Orthopaedic Implant Company, The162%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PI GALILEO JOURNEYTC-PLUSApexUnity Total Knee SystemOrthoSolutions 'System26' Bone ScrewsOXFORD ANKLE FUSION NAIL(AFN) SYSTEMTrinity Acetabular Hip SystemTrinity Acetabular Hip System with HXLPE LinersRotaglide+ Modular Knee System with Fixed MeniscUniglide Unicondylar Knee ProsthesisCormet 2000 Hemi-Hip Metallic Resurfacing ProsthOXFORD UNICOMPARTMENTAL KNEE PHASE 3OXFORD UNICOMPARTMENTAL KNEE PHASE 3SHIM SIZE 3OXFORD UNICOMPARTMENTAL KNEE PHASE 3SHIM SIZE 2OXFORD UNICOMPARTMENTAL KNEE PHASE 3SHIM SIZE 1OXFORD® UNICOMPARTMENTAL KNEE PHASE 3TIBIAL RESE

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 INSTRUMENT170
MDMInstrument, Manual, Surgical, General Use142
FZXGuide, surgical, instrument115
LXHOrthopedic Manual Surgical Instrument79
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM75
HWCScrew, Fixation, Bone50

GMDN & GCC registration

  • GMDN code 47815 · non‑implantable
  • Single‑use 4% · sterile 3% · Rx‑only 96% · 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

Angle (degree) · 7Outer Diameter (Millimeter) · 5Length (Millimeter) · 4Width (Millimeter) · 2Height (Millimeter) · 1

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

How many orthopaedic implant aiming/guiding block, reusable products are registered in the US?

944 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant aiming/guiding block, reusable", from 30 companies. The largest labeler is Wright Medical Technology, Inc. with 15% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), MDM (Instrument, Manual, Surgical, General Use), FZX (Guide, 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.

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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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