Consulting Wallah › Device Explorer › Orthopaedic implants › External lower-limb prosthesis structural/alignmen
Device Explorer · FDA GUDID · GMDN 61229

External lower-limb prosthesis structural/alignment component

A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prost

US‑registered devices236in commercial distribution
Companies8labelers on GUDID
Single‑use22%of device records
Sterile0%labelled sterile
Prescription11%Rx‑only share
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Share of device records

College Park Industries, Inc.12151%
Trulife Limited4017%
Teh Lin Prosthetic & Orthopaedic Inc.3515%
C Lindhextend Ab136%
Osseointegration International Pty Ltd136%
Vessl Prosthetics Inc125%
Care Surgical Limited10%
Streifeneder Ortho.Production Gmbh10%

Top labelers

CompanyDevicesShare
College Park Industries, Inc.12151%
Trulife Limited4017%
Teh Lin Prosthetic & Orthopaedic Inc.3515%
C Lindhextend Ab136%
Osseointegration International Pty Ltd136%
Vessl Prosthetics Inc125%
Care Surgical Limited10%
Streifeneder Ortho.Production Gmbh10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Xtend Connect A100Xtend Connect Shape A200CS Carbon Spine Extension FrameTEHLINSocket Attachment Block block Ø 148 mmEndoskeletal ComponentsC100 Cylindrical Shuttle LockTrulifeKinn Automatic Volume Management SystemTorsion AdapterOsseointegration Prosthetic Limb

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

FDA product codes

CodeNameDevices
IQODevice, Prosthesis Alignment134
ISHCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT43
IQQJoint, Shoulder, External Limb Component35
ISHComponent, External, Limb, Ankle/Foot13
BWNTable And Attachments, Operating-Room1
ISYJoint, Knee, External Limb Component1

GMDN & GCC registration

  • GMDN code 61229 · non‑implantable
  • Single‑use 22% · sterile 0% · Rx‑only 11% · OTC 17%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many external lower-limb prosthesis structural/alignment component products are registered in the US?

236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External lower-limb prosthesis structural/alignment component", from 8 companies. The largest labeler is College Park Industries, Inc. with 51% of records.

Which FDA product codes apply?

IQO (Device, Prosthesis Alignment), ISH (COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT), IQQ (Joint, Shoulder, External Limb Component), ISH (Component, External, Limb, Ankle/Foot)

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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