Consulting Wallah › Device Explorer › Other devices › External orthopaedic fixation system, single-use
Device Explorer · FDA GUDID · GMDN 48011

External orthopaedic fixation system, single-use

An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins

US‑registered devices4,156in commercial distribution
Companies33labelers on GUDID
Single‑use96%of device records
Sterile4%labelled sterile
Prescription92%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.88421%
Biomet Orthopedics, Llc76118%
Vilex In Tennessee, Inc.51012%
Hnm Total Recon Llc2306%
Wright Medical Technology, Inc.2165%
Paragon 28, Inc.1874%
Sequel Medical Inc.1724%
Orthofix Srl1514%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.88421%
Biomet Orthopedics, Llc76118%
Vilex In Tennessee, Inc.51012%
Hnm Total Recon Llc2306%
Wright Medical Technology, Inc.2165%
Paragon 28, Inc.1874%
Sequel Medical Inc.1724%
Orthofix Srl1514%
Eminent Spine Llc1413%
Vilex Llc1333%
Life Spine, Inc.1303%
Globus Medical, Inc.1073%

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

Brand names on the register (sample)

INSTRUMENTPOLARSTEMSchanz Pin 5.0 mm dia. 190 mm long Trokar point,IOSmahe medical GmbHILIZAROV SYSTEMSJet-XSPATIAL FRAMENAOTHER EXTERNAL FIXATIONJet-X CentralHEX-FIXILIZAROVOTHER EXFIXNo BrandHEX FIX

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

FDA product codes

CodeNameDevices
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple 2,565
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 1,810
JDWPIN, FIXATION, THREADED775
HRSPlate, Fixation, Bone345
JDWPin, Fixation, Threaded245
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 159

GMDN & GCC registration

  • GMDN code 48011 · implantable
  • Single‑use 96% · sterile 4% · Rx‑only 92% · 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) · 123Width (Millimeter) · 111Outer Diameter (Millimeter) · 64Lumen/Inner Diameter (Millimeter) · 37Height (Millimeter) · 8Length (Inch) · 5

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

How many external orthopaedic fixation system, single-use products are registered in the US?

4,156 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External orthopaedic fixation system, single-use", from 33 companies. The largest labeler is Smith & Nephew, Inc. with 21% of records.

Which FDA product codes apply?

KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ), KTT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE ), JDW (PIN, FIXATION, THREADED), HRS (Plate, Fixation, Bone)

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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