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Device Explorer · FDA GUDID · GMDN 61917

Osteotomy guide, reusable

A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscil

US‑registered devices2,677in commercial distribution
Companies50labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Ortho Development Corporation73227%
Smith & Nephew, Inc.47518%
Exactech, Inc.30912%
United Orthopedic Corp.29311%
Wright Medical Technology, Inc.1355%
B-One Ortho, Corp.923%
Tornier, Inc.733%
Paragon 28, Inc.662%

Top labelers

CompanyDevicesShare
Ortho Development Corporation73227%
Smith & Nephew, Inc.47518%
Exactech, Inc.30912%
United Orthopedic Corp.29311%
Wright Medical Technology, Inc.1355%
B-One Ortho, Corp.923%
Tornier, Inc.733%
Paragon 28, Inc.662%
Orthopediatrics Corp.552%
Treace Medical Concepts, Inc.532%
Vilex Llc502%
In2Bones422%

Company = labeler of record on GUDID. 50 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

The Locking Pediatric Osteotomy Plate (LolliPOP)N/ANAOsteotec CBG Guide LOsteotec CBG Guide SMAXIM KNEE INSTRUMENTATIONU2 Total Knee SystemUSTAR II Knee SystemU-Wise Hip Surgical Guide TemplateU2™ KneeMIS Distal femoral cutting guideUKNEE™UCP™ StemUTF™ StemU2™ HipConformity Stem

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 INSTRUMENT484
FZXGuide, surgical, instrument458
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM441
LXHOrthopedic Manual Surgical Instrument388
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 251
LXHOrthopedic manual surgical instrument225

GMDN & GCC registration

  • GMDN code 61917 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 70% · 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) · 111Length (Millimeter) · 47Height (Millimeter) · 46Width (Millimeter) · 19Depth (Millimeter) · 11Lumen/Inner Diameter (Millimeter) · 9

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

How many osteotomy guide, reusable products are registered in the US?

2,677 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Osteotomy guide, reusable", from 50 companies. The largest labeler is Ortho Development Corporation with 27% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, surgical, instrument), 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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