Consulting Wallah › Device Explorer › Other devices › Subtalar implant, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 40352

Subtalar implant, non-bioabsorbable

A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities; it is n

US‑registered devices87in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile78%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Wright Medical Technology, Inc.2124%
Biopro, Inc.1821%
Graham Medical Technologies, L.L.C.1315%
Fusion Orthopedics, Llc89%
Ascension Orthopedics, Inc.89%
Brm Extremities Srl78%
Hnm Total Recon Llc67%
Smith & Nephew, Inc.56%

Top labelers

CompanyDevicesShare
Wright Medical Technology, Inc.2124%
Biopro, Inc.1821%
Graham Medical Technologies, L.L.C.1315%
Fusion Orthopedics, Llc89%
Ascension Orthopedics, Inc.89%
Brm Extremities Srl78%
Hnm Total Recon Llc67%
Smith & Nephew, Inc.56%
Osteomed Llc11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Subtalar MBA Implant SystemOsteoMedCORVUSSUBTALAR SPACER SYSTEMSTA-PEGBIOARCHPolyLockLSI Arthroereisis PegHyProCure II Sinus Tarsi Stent Size 12HyProCure II Sinus Tarsi Stent Size 11HyProCure II Sinus Tarsi Stent Size 10HyProCure II Sinus Tarsi Stent Size 09HyProCure II Sinus Tarsi Stent Size 08HyProCure II Sinus Tarsi Stent Size 07HyProCure II Sinus Tarsi Stent Size 06HyProCure Size 10

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

FDA product codes

CodeNameDevices
HWCScrew, Fixation, Bone89
HWCScrew, fixation, bone39
MJWProsthesis, Subtalar, Plug, Polymer11
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT5
MBJFastener, Fixation, Biodegradable, Hard Tissue5

GMDN & GCC registration

  • GMDN code 40352 · implantable
  • Single‑use 100% · sterile 78% · Rx‑only 93% · 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

Outer Diameter (Millimeter) · 20Width (Millimeter) · 12Height (Millimeter) · 12Length (Millimeter) · 10

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

How many subtalar implant, non-bioabsorbable products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Subtalar implant, non-bioabsorbable", from 9 companies. The largest labeler is Wright Medical Technology, Inc. with 24% of records.

Which FDA product codes apply?

HWC (Screw, Fixation, Bone), HWC (Screw, fixation, bone), MJW (Prosthesis, Subtalar, Plug, Polymer), 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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