An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such a
| Company | Devices | Share |
|---|---|---|
| Citieffe Srl | 101 | 34% |
| Biomet Orthopedics, Llc | 83 | 28% |
| Vilex In Tennessee, Inc. | 53 | 18% |
| Vilex Llc | 33 | 11% |
| Orthofix Srl | 9 | 3% |
| Smith & Nephew, Inc. | 5 | 2% |
| Nutek Orthopaedics Inc | 4 | 1% |
| Zimmer, Inc. | 3 | 1% |
| A.M. Surgical, Inc. | 3 | 1% |
Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| JDW | Pin, Fixation, Threaded | 220 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple | 144 |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE | 94 |
| HWC | Screw, fixation, bone | 69 |
| JDW | PIN, FIXATION, THREADED | 10 |
| LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE | 9 |
Use these as the dimensions to specify in a tender line.
294 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External orthopaedic fixation system, single-use, sterile", from 9 companies. The largest labeler is Citieffe Srl with 34% of records.
JDW (Pin, Fixation, Threaded), KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ), KTT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE ), HWC (Screw, fixation, bone)
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.