# K211290: Cannulated Fasteners and Nuts

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Aug 3, 2021 after 97 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: 13 generations back to K962616 (1996). 137 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210754: Cannulated Fasteners and Nuts, OsteoCentric Technologies (2021) Summary page 5.
- K170021: SMV Scientific Cannulated Screws, Smv Scientific (2017) Summary page 5.
- K193214: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws, Biomet, Inc. (2020) Summary page 5.
- K190324: OrthoPediatrics Cannulated Screw System, OrthoPediatrics Corp. (2019) Summary page 5.

## Most influential descendants
- 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 and 3.0mm Cannulated Screw are 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 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation. The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, 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 (e.g. 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/K211290
Methodology: https://510kreport.com/methodology