# K162153: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics
- Decided: Jul 14, 2017 after 346 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: 9 generations back to K962616 (1996). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 4.
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K060026: Koby Surgical Internal Fixation System, Koby Surgical (2006) Summary page 4.

## Most influential descendants
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (2021), 0 descendants of its own

## Indications for use
The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

Source page: https://510kreport.com/device/K162153
Methodology: https://510kreport.com/methodology