Consulting Wallah › Device Explorer › Orthopaedic implants › Diaphysis prosthesis
Device Explorer · FDA GUDID · GMDN 58084

Diaphysis prosthesis

An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/

US‑registered devices227in commercial distribution
Companies3labelers on GUDID
Single‑use71%of device records
Sterile71%labelled sterile
Prescription56%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Merete Gmbh16573%
Biomet Orthopedics, Llc3917%
Waldemar Link Gmbh & Co. Kg2310%

Top labelers

CompanyDevicesShare
Merete Gmbh16573%
Biomet Orthopedics, Llc3917%
Waldemar Link Gmbh & Co. Kg2310%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OsteoBridge™OsteoBridge™ IDSF DiaphysisOsteoBridge™ IDSF Diaphysis Femoral SpacerOsteoBridge™ IDSF Diaphysis Tibial SpacerOsteoBridge™ IDSF Diaphysis Humeral SpacerOsteoBridge™ IDSF Diaphysis Femoral NailOsteoBridge™ IDSF Diaphysis Tibial NailOsteoBridge™ IDSF Diaphysis Humeral NailOsteoBridge™ Interlocking ScrewOsteoBridge™ IDSF Diaphysis Interlocking ScrewMegasystem COSS™ Orthopedic Salvage SystemORTHOPEDIC SALVAGE SYSTEM (OSS)

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

FDA product codes

CodeNameDevices
HSBRod, Fixation, Intramedullary And Accessories187
HWTTEMPLATE86
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented39
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL39
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC27
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce27

GMDN & GCC registration

  • GMDN code 58084 · implantable
  • Single‑use 71% · sterile 71% · Rx‑only 56% · 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) · 161Length (Millimeter) · 144Outer Diameter (Micrometer) · 2

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

No closely related category with 50+ devices.

How many diaphysis prosthesis products are registered in the US?

227 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diaphysis prosthesis", from 3 companies. The largest labeler is Merete Gmbh with 73% of records.

Which FDA product codes apply?

HSB (Rod, Fixation, Intramedullary And Accessories), HWT (TEMPLATE), 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.

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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