Consulting Wallah › Device Explorer › Other devices › Orthopaedic cement restrictor sizer
Device Explorer · FDA GUDID · GMDN 61247

Orthopaedic cement restrictor sizer

A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the

US‑registered devices125in commercial distribution
Companies6labelers on GUDID
Single‑use18%of device records
Sterile0%labelled sterile
Prescription73%Rx‑only share
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Share of device records

Genesys Orthopedics Systems Llc5746%
Cutting Edge Spine, Llc3427%
Biomet Orthopedics, Llc2621%
Teknimed65%
Zimmer, Inc.11%
Astura Medical11%

Top labelers

CompanyDevicesShare
Genesys Orthopedics Systems Llc5746%
Cutting Edge Spine, Llc3427%
Biomet Orthopedics, Llc2621%
Teknimed65%
Zimmer, Inc.11%
Astura Medical11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CEMSTOP INSTRUMENTATIONCPT®Biomet® General Hip InstrumentsDISTAL CANAL SIZERBIO PLUG PROV. SETBIO-PLUG TRIALBIO-PLUGALTAEVOL®ha-C Cervical Interbody System3DP Lumbar Interbody System

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

FDA product codes

CodeNameDevices
ODPIntervertebral Fusion Device With Bone Graft, Cervical57
MQPSpinal Vertebral Body Replacement Device57
MAXIntervertebral Fusion Device With Bone Graft, Lumbar57
ODPIntervertebral fusion device with bone graft, cervical34
HWTTEMPLATE23
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT21

GMDN & GCC registration

  • GMDN code 61247 · non‑implantable
  • Single‑use 18% · sterile 0% · Rx‑only 73% · 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) · 77Angle (degree) · 43

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

How many orthopaedic cement restrictor sizer products are registered in the US?

125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic cement restrictor sizer", from 6 companies. The largest labeler is Genesys Orthopedics Systems Llc with 46% of records.

Which FDA product codes apply?

ODP (Intervertebral Fusion Device With Bone Graft, Cervical), MQP (Spinal Vertebral Body Replacement Device), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), ODP (Intervertebral fusion device with bone graft, cervical)

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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