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Device Explorer · FDA GUDID · GMDN 61687

Phalangeal joint arthrodesis implant

A small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically

US‑registered devices158in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Adsm3522%
Tyber Medical, Llc3522%
Paragon 28, Inc.2013%
In2Bones Usa, Llc1811%
Wright Medical Technology, Inc.1610%
Biomedical Enterprises, Inc.128%
Neosteo64%
Synthes Gmbh64%

Top labelers

CompanyDevicesShare
Adsm3522%
Tyber Medical, Llc3522%
Paragon 28, Inc.2013%
In2Bones Usa, Llc1811%
Wright Medical Technology, Inc.1610%
Biomedical Enterprises, Inc.128%
Neosteo64%
Synthes Gmbh64%
Bioseal43%
Intelivation, Llc43%
Newdeal21%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DUAFITDuaFit®DynafitSystemTOEGRIP® RetrogradeTOEGRIP® RetrogradeTOEGRIP® EVOTOEGRIP® ClassicHammerTube™ SystemHammerTube SystemPRO-TOEPHALINXSWANSONHammerLock2HammerLockBioseal Inc.TOEGRIP® CLASSIC

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

FDA product codes

CodeNameDevices
HTYPin, Fixation, Smooth80
HTYPIN, FIXATION, SMOOTH57
HWCScrew, Fixation, Bone21
HWCScrew, fixation, bone14
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER11
KDCINSTRUMENT, SURGICAL, DISPOSABLE4

GMDN & GCC registration

  • GMDN code 61687 · implantable
  • Single‑use 100% · sterile 92% · Rx‑only 97% · 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) · 47Length (Millimeter) · 28Outer Diameter (Millimeter) · 4

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

How many phalangeal joint arthrodesis implant products are registered in the US?

158 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Phalangeal joint arthrodesis implant", from 11 companies. The largest labeler is Adsm with 22% of records.

Which FDA product codes apply?

HTY (Pin, Fixation, Smooth), HTY (PIN, FIXATION, SMOOTH), HWC (Screw, Fixation, Bone), HWC (Screw, 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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