Consulting Wallah › Device Explorer › Other devices › Orthopaedic cement spacer mould
Device Explorer · FDA GUDID · GMDN 45105

Orthopaedic cement spacer mould

A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled wit

US‑registered devices142in commercial distribution
Companies5labelers on GUDID
Single‑use92%of device records
Sterile85%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc7351%
G21 Srl3726%
Ortho Development Corporation128%
United Orthopedic Corp.118%
Berkeley Advanced Biomaterials, Llc96%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc7351%
G21 Srl3726%
Ortho Development Corporation128%
United Orthopedic Corp.118%
Berkeley Advanced Biomaterials, Llc96%

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

Brand names on the register (sample)

Cellbrick Knee SpacerRepliCase™STAGEONE SELECTStageOne SelectStageOne™CEMENTONSTAGEONEPutty Convenience Kit, 10ccPutty Convenience Kit, 5ccSURESPACEKASMThriveSynth™ Putty Convenience KitCemSyntek Putty Convenience Kit 10ccCemSyntek Putty Convenience Kit 5ccCemSyntek Putty Convenience Kit 2.5ccPutty Convenience Kit, 2.5cc

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

FDA product codes

CodeNameDevices
MBBBONE CEMENT, ANTIBIOTIC63
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM46
MBBBone Cement, Antibiotic37
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement30
KWLProsthesis, hip, hemi-, femoral, metal29
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 29

GMDN & GCC registration

  • GMDN code 45105 · non‑implantable
  • Single‑use 92% · sterile 85% · Rx‑only 79% · 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) · 12Width (Millimeter) · 12

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

How many orthopaedic cement spacer mould products are registered in the US?

142 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic cement spacer mould", from 5 companies. The largest labeler is Biomet Orthopedics, Llc with 51% of records.

Which FDA product codes apply?

MBB (BONE CEMENT, ANTIBIOTIC), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBB (Bone Cement, Antibiotic), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement)

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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