# K210754: Cannulated Fasteners and Nuts

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Apr 14, 2021 after 30 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 114 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170021: SMV Scientific Cannulated Screws, Smv Scientific (2017) Summary page 5.
- K202680: OsteoMed ExtremiFix Mini & Small Cannulated Screw System, Osteomed, LLC (2020) Summary page 5.
- K191344: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module, Arthrex, Inc. (2019) Summary page 5.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 5.
- K081813: Universal Compression Fracture Repair System, U.S. Implant Solutions, LLC (2009) Summary page 5.
- K150981: SMV Scientific Bone Screws, Smv Scientific (2015) Summary page 5.

## Most influential descendants
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis. The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.

Source page: https://510kreport.com/device/K210754
Methodology: https://510kreport.com/methodology