Device Explorer · FDA GUDID · GMDN 41435

Foot orthosis

A device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload

US‑registered devices182in commercial distribution
Companies8labelers on GUDID
Single‑use63%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Bird & Cronin, Llc11563%
Djo, Llc3218%
Medical Specialties Incorporated105%
Alimed, Inc.84%
Pantymed S.A.74%
Silipos Holding Llc53%
Vive Health Llc42%
Ambroise Holland B.V.11%

Top labelers

CompanyDevicesShare
Bird & Cronin, Llc11563%
Djo, Llc3218%
Medical Specialties Incorporated105%
Alimed, Inc.84%
Pantymed S.A.74%
Silipos Holding Llc53%
Vive Health Llc42%
Ambroise Holland B.V.11%

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

Brand names on the register (sample)

DONJOY PERFORMANCEDONJOYPROCAREAIRCASTVIVEVivePhantom Dorsal Night SplintPhantom Dorsal NIght Splint with Toe StrapINSOLE D-SOLE 1/4IN THICKINSOLE D-SOLE 1/8IN THICK"""Day & Night Gel Bunion Splint, 1pc/bag (w/ geSilopad Softsock, White, XLarge, Size 13-16Silopad Softsock, White, Large, Size 10-13Silopad Softsock, White, Medium, Size 9-11Silopad Softsock, White, Small, Size 7-9POST-OP SHOE DLX 2 MALE XL

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

FDA product codes

CodeNameDevices
KNPOrthosis, Corrective Shoe115
KYSINSOLES, MEDICAL32
ITWJoint, Ankle, External Brace13
KNPORTHOSIS, CORRECTIVE SHOE8
IQIOrthosis, Limb Brace8
FMPProtector, Skin Pressure5

GMDN & GCC registration

  • GMDN code 41435 · non‑implantable
  • Single‑use 63% · sterile 0% · Rx‑only 0% · OTC 18%
  • 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.

No closely related category with 50+ devices.

How many foot orthosis products are registered in the US?

182 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Foot orthosis", from 8 companies. The largest labeler is Bird & Cronin, Llc with 63% of records.

Which FDA product codes apply?

KNP (Orthosis, Corrective Shoe), KYS (INSOLES, MEDICAL), ITW (Joint, Ankle, External Brace), KNP (ORTHOSIS, CORRECTIVE SHOE)

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?

Add foot orthosis to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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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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