Consulting Wallah › Device Explorer › Other devices › Body femoral/tibial extension stem, uncoated
Device Explorer · FDA GUDID · GMDN 61561

Body femoral/tibial extension stem, uncoated

A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid

US‑registered devices189in commercial distribution
Companies5labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Onkos Surgical, Inc.9349%
Waldemar Link Gmbh & Co. Kg6836%
Omni Life Science, Inc.147%
Adler Ortho Spa126%
Conformis, Inc.21%

Top labelers

CompanyDevicesShare
Onkos Surgical, Inc.9349%
Waldemar Link Gmbh & Co. Kg6836%
Omni Life Science, Inc.147%
Adler Ortho Spa126%
Conformis, Inc.21%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Endo-Model Knee System - InstrumentsLink OptiStemAPEX Knee SystemOMNI KneeELEOS™ELEOS Limb Salvage SystemiTotal® Identity Cruciate Retaining Knee ReplacePantheon System

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

FDA product codes

CodeNameDevices
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL127
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented61
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented44
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal32
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN14
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM14

GMDN & GCC registration

  • GMDN code 61561 · implantable
  • Single‑use 99% · sterile 99% · Rx‑only 100% · 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

Length (Millimeter) · 14

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

No closely related category with 50+ devices.

How many body femoral/tibial extension stem, uncoated products are registered in the US?

189 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Body femoral/tibial extension stem, uncoated", from 5 companies. The largest labeler is Onkos Surgical, Inc. with 49% of records.

Which FDA product codes apply?

KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal)

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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