Consulting Wallah › Device Explorer › Orthopaedic implants › Orthopaedic bone screw, non-bioabsorbable, sterile
Device Explorer · FDA GUDID · GMDN 46646

Orthopaedic bone screw, non-bioabsorbable, sterile

"A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue t

US‑registered devices19,365in commercial distribution
Companies59labelers on GUDID
Single‑use100%of device records
Sterile79%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc3,88720%
Smith & Nephew, Inc.2,24412%
Orthofix Srl2,09111%
Osteomed Llc1,96010%
Orthopediatrics Corp.1,3067%
Globus Medical, Inc.1,2787%
Flower Orthopedics Corporation1,0836%
Wright Medical Technology, Inc.9015%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc3,88720%
Smith & Nephew, Inc.2,24412%
Orthofix Srl2,09111%
Osteomed Llc1,96010%
Orthopediatrics Corp.1,3067%
Globus Medical, Inc.1,2787%
Flower Orthopedics Corporation1,0836%
Wright Medical Technology, Inc.9015%
Ortho Solutions Holdings Limited7024%
Biopro, Inc.5593%
Gramercy Extremity Orthopedics Llc5543%
Citieffe Srl4632%

Company = labeler of record on GUDID. 59 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

POLARCUPNo BrandCyclaPlex ImplantTI HBS self-drilling high compression screw,cannCort. tit. TX-screw, Ø2.7mm,L.50mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.50mm,T10Cort. tit. TX-screw, Ø2.7mm,L.48mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.48mm,T10Cort. tit. TX-screw, Ø2.7mm,L.46mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.46mm,T10Cort. tit. TX-screw, Ø2.7mm,L.44mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.44mm,T10Cort. tit. TX-screw, Ø2.7mm,L.40mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.40mm,T10Cort. tit. TX-screw, Ø2.7mm,L.38mm,T10Cort.tit. PTXL-screw,Ø2.7mm,L.38mm,T10

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

FDA product codes

CodeNameDevices
HWCScrew, fixation, bone9,509
HWCScrew, Fixation, Bone4,338
HRSPLATE, FIXATION, BONE4,005
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1,916
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 1,542
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 1,426

GMDN & GCC registration

  • GMDN code 46646 · non‑implantable
  • Single‑use 100% · sterile 79% · 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

Length (Millimeter) · 7,584Outer Diameter (Millimeter) · 5,007Width (Millimeter) · 140Height (Millimeter) · 45Angle (degree) · 19Outer Diameter (Inch) · 15

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

How many orthopaedic bone screw, non-bioabsorbable, sterile products are registered in the US?

19,365 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone screw, non-bioabsorbable, sterile", from 59 companies. The largest labeler is Biomet Orthopedics, Llc with 20% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), HWC (Screw, Fixation, Bone), HRS (PLATE, FIXATION, BONE), HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES)

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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