Consulting Wallah › Device Explorer › Other devices › Orthopaedic cement spacer
Device Explorer · FDA GUDID · GMDN 33982

Orthopaedic cement spacer

A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-

US‑registered devices284in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Osteoremedies, Llc8028%
Biomet Orthopedics, Llc7827%
Howmedica Osteonics Corp.4415%
Tecres Spa2810%
Biocomposites Ltd248%
Heraeus Medical Gmbh135%
Microport Orthopedics Inc.135%
G21 Srl41%

Top labelers

CompanyDevicesShare
Osteoremedies, Llc8028%
Biomet Orthopedics, Llc7827%
Howmedica Osteonics Corp.4415%
Tecres Spa2810%
Biocomposites Ltd248%
Heraeus Medical Gmbh135%
Microport Orthopedics Inc.135%
G21 Srl41%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AccoladeOmnifitPlugCOPAL® exchange GDistal Centralizer/Centering SleeveAnswer® / Impact® / Integral® Hip SystemSTANMORE™ HIP SYSTEMSIRIUS HIP SYSTEMSTANMORE HIP SYSTEMCEMENTED HIP SYSTEMFEMORAL CENTERING SLEEVEGENERATION 4 HIP SYSTEMAnswer / Impact / Integral Hip SystemANSWER / IMPACT / INTEGRAL HIP SYSTEMSCREW SYSTEMBIO-MODULAR SHOULDER SYSTEM

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, Antibiotic69
KWLProsthesis, Hip, Hemi-, Femoral, Metal65
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce60
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 56
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented43
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem41

GMDN & GCC registration

  • GMDN code 33982 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 89% · 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) · 18Length (Millimeter) · 18

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

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

284 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic cement spacer", from 8 companies. The largest labeler is Osteoremedies, Llc with 28% of records.

Which FDA product codes apply?

MBB (Bone Cement, Antibiotic), KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or )

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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