Consulting Wallah › Device Explorer › Orthopaedic implants › Implantable orthopaedic/craniofacial device connec
Device Explorer · FDA GUDID · GMDN 63998

Implantable orthopaedic/craniofacial device connection screw

A small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically

US‑registered devices216in commercial distribution
Companies17labelers on GUDID
Single‑use97%of device records
Sterile33%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Fusion Orthopedics, Llc8138%
Sky Surgical, Llc2411%
Implantcast Gmbh2210%
Skeletal Dynamics L.L.C.209%
Waldemar Link Gmbh & Co. Kg188%
Pioneer Surgical Technology, Inc.115%
Synthes Gmbh94%
Orthopediatrics Canada Ulc63%

Top labelers

CompanyDevicesShare
Fusion Orthopedics, Llc8138%
Sky Surgical, Llc2411%
Implantcast Gmbh2210%
Skeletal Dynamics L.L.C.209%
Waldemar Link Gmbh & Co. Kg188%
Pioneer Surgical Technology, Inc.115%
Synthes Gmbh94%
Orthopediatrics Canada Ulc63%
Orthopediatrics Corp.52%
Total Joint Orthopedics, Inc.42%
Adler Ortho Spa42%
Depuy Orthopaedics, Inc.31%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

The Locking Pediatric Osteotomy Plate (LolliPOP)GAP ENDO-EXO MEDULLARY SYSTEMn/asafety screwACS®MUTARS® screwMUTARS® safety screwMUTARS® screw for connecting partLINK Endo-Model EVO Knee SystemLINK Endo-Model EVOLink OptiStemGemini SL Total Knee SystemLineSiderNCB®SkyOPSHex Button

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, Bone105
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce23
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL16
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES15
HTNWASHER, BOLT NUT15
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem6

GMDN & GCC registration

  • GMDN code 63998 · implantable
  • Single‑use 97% · sterile 33% · Rx‑only 100% · 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) · 14Outer Diameter (Millimeter) · 4

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

How many implantable orthopaedic/craniofacial device connection screw products are registered in the US?

216 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Implantable orthopaedic/craniofacial device connection screw", from 17 companies. The largest labeler is Fusion Orthopedics, Llc with 38% of records.

Which FDA product codes apply?

HWC (Screw, Fixation, Bone), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), 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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