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Device Explorer · FDA GUDID · GMDN 61669

Orthopaedic bone staple, non-adjustable

A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformitie

US‑registered devices1,304in commercial distribution
Companies44labelers on GUDID
Single‑use98%of device records
Sterile82%labelled sterile
Prescription88%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Crossroads Extremity Systems14111%
Stryker Gmbh12410%
Biomedical Enterprises, Inc.907%
Smith & Nephew, Inc.766%
Arthrex, Inc.746%
Synthes Gmbh514%
Wright Medical Technology, Inc.504%
Ortho Solutions Holdings Limited474%

Top labelers

CompanyDevicesShare
Crossroads Extremity Systems14111%
Stryker Gmbh12410%
Biomedical Enterprises, Inc.907%
Smith & Nephew, Inc.766%
Arthrex, Inc.746%
Synthes Gmbh514%
Wright Medical Technology, Inc.504%
Ortho Solutions Holdings Limited474%
Treace Medical Concepts, Inc.474%
Biopro, Inc.474%
Newdeal423%
Hnm Total Recon Llc413%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EASYCLIPEASYSTEPNASMART TOE4FUSIONEASY CLIPX-FUSEMEMOCLIPEliteOSSIOfiber® Compression StapleOSSIOfiber® Compression Staple SystemCOGNiTiON™ Staple SystemORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR XIA 4 5Z-StaplePediatrOS™ RigidTack™

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

FDA product codes

CodeNameDevices
JDRStaple, Fixation, Bone770
JDRSTAPLE, FIXATION, BONE266
JDRStaple, fixation, bone239
HRSPlate, Fixation, Bone84
HWCScrew, Fixation, Bone55
MNHOrthosis, spondylolisthesis spinal fixation32

GMDN & GCC registration

  • GMDN code 61669 · implantable
  • Single‑use 98% · sterile 82% · Rx‑only 88% · 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) · 304Width (Millimeter) · 275Depth (Millimeter) · 33Angle (degree) · 21Height (Millimeter) · 20Outer Diameter (Millimeter) · 3

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

How many orthopaedic bone staple, non-adjustable products are registered in the US?

1,304 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone staple, non-adjustable", from 44 companies. The largest labeler is Crossroads Extremity Systems with 11% of records.

Which FDA product codes apply?

JDR (Staple, Fixation, Bone), JDR (STAPLE, FIXATION, BONE), JDR (Staple, fixation, bone), HRS (Plate, Fixation, Bone)

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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