# K993762: I.CO.S Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Feb 4, 2000 after 88 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: 1 generation back to K962823 (1996). 3 ancestors in all.
338 later devices descend from it; 3 cite it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963420: Cancellous Screw Washer, Orthopaedic Biosystems, Ltd. (1996) Summary page 2.
- K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM, Aap Implantate AG (1999) Summary page 2.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 2.

## Most influential descendants
- K024233: Kompressor Screw System (2003), 299 descendants of its own
- K040356: Kompressor Screw System (2004), 255 descendants of its own
- K060071: Nexa Compression Screw (2006), 251 descendants of its own
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own

## Indications for use
The ICOS ® SCREW is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including; *naviculo-cunéiform arthrodesis *lapidus arthrodesis *talus osteochondritis *ankle arthrodesis *arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.

Source page: https://510kreport.com/device/K993762
Methodology: https://510kreport.com/methodology