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Device Explorer · FDA GUDID · GMDN 61559

Femur/tibia shaft prosthesis

A sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve f

US‑registered devices514in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription10%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Rootloc Co., Ltd.46590%
Biomet Orthopedics, Llc265%
Implantcast Gmbh194%
Onkos Surgical, Inc.41%

Top labelers

CompanyDevicesShare
Rootloc Co., Ltd.46590%
Biomet Orthopedics, Llc265%
Implantcast Gmbh194%
Onkos Surgical, Inc.41%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ACS®OSS™ Orthopedic Salvage SystemORTHOPEDIC SALVAGE SYSTEMMAXIM KNEE SYSTEMELEOS™CentLoc Total Knee SystemCentLoc Total Knee Systerm

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

FDA product codes

CodeNameDevices
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem484
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL30
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented30
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM17
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE11
KWZProsthesis, hip, constrained, cemented or uncemented, metal/11

GMDN & GCC registration

  • GMDN code 61559 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 10% · 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.

How many femur/tibia shaft prosthesis products are registered in the US?

514 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Femur/tibia shaft prosthesis", from 4 companies. The largest labeler is Rootloc Co., Ltd. with 90% of records.

Which FDA product codes apply?

JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM)

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?

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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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