# K121682: Active Screw Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Implant Systems, LLC
- Decided: Oct 4, 2012 after 119 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: 3 generations back to K082320 (2008). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961157: Whiteside Biomechanics Cancellous Bone Screw, Whiteside Biomechanics, Inc. (1996) Summary page 1.
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K112772: Ortholoc (TM) Bone Screws, Wrightmedicaltechnologyinc (2011)
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 1.

## Indications for use
The ACTIVETM Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K121682
Methodology: https://510kreport.com/methodology