Consulting Wallah › Device Explorer › Orthopaedic implants › Internal-external leg prosthesis osseointegration
Device Explorer · FDA GUDID · GMDN 58743

Internal-external leg prosthesis osseointegration bar

A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis.

US‑registered devices151in commercial distribution
Companies1labelers on GUDID
Single‑use83%of device records
Sterile73%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Integrum Ab151100%

Top labelers

CompanyDevicesShare
Integrum Ab151100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Instrument Kit: Abutment Screw Adjustment GInstrument Kit: Hammer System F/ GFixture Removal Guide Pins Kit Platform GOPRA™ Implant System Drill-bit 11,7 mmOPRA™ Implant System Abutment 12x78 +10OPRA™ Implant System Abutment 12x78 +9OPRA™ Implant System Abutment 12x78 +8OPRA™ Implant System Abutment 12x78 +7OPRA™ Implant System Abutment 12x78 +6OPRA™ Implant System Abutment 12x78 +5OPRA™ Implant System Abutment 12x78 +4OPRA™ Implant System Abutment 12x78 +3OPRA™ Implant System Abutment 12x78 +2OPRA™ Implant System Abutment 12x78 +1Instrument Kit Marrow Blood SampleInstrument Kit: Fixture Removal PF G USA

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

FDA product codes

CodeNameDevices
PJYTransfemoral Percutaneous Prosthetic119
PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemo33

GMDN & GCC registration

  • GMDN code 58743 · implantable
  • Single‑use 83% · sterile 73% · Rx‑only 99% · 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

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 internal-external leg prosthesis osseointegration bar products are registered in the US?

151 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal-external leg prosthesis osseointegration bar", from 1 companies. The largest labeler is Integrum Ab with 100% of records.

Which FDA product codes apply?

PJY (Transfemoral Percutaneous Prosthetic), PJY (Osseoanchored Prostheses For The Rehabilitation Of Transfemo)

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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