# K222409: CAPTIVATE® Compression Screws

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Sep 8, 2022 after 29 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: 14 generations back to K962616 (1996). 144 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162825: CAPTIVATE™ Compression Screws, Globus Medical, Inc. (2017) Summary page 4.
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014) Summary page 4.
- K190586: Monster® Screw System, Paragon 28, Inc. (2019) Summary page 4.

## Most influential descendants
- K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (2023), 0 descendants of its own

## Indications for use
CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

Source page: https://510kreport.com/device/K222409
Methodology: https://510kreport.com/methodology