# K162825: CAPTIVATE™ Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: May 1, 2017 after 206 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: 11 generations back to K962616 (1996). 92 ancestors in all.
74 later devices descend from it; 3 cite it directly.
1 of 167 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143039: CrossRoads Screw System, Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem (2015) Summary page 4.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 4.
- K090949: Synthes (Usa) 1.5MM Headless Compression Screws, Synthes (Usa) (2009) Summary page 4.

## Most influential descendants
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K211616: ExcelsiusHub (2021), 9 descendants of its own
- K220862: E-GPS Navigated Instruments (2022), 7 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/K162825
Methodology: https://510kreport.com/methodology