# K011821: Modification to the I.C.O.S Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Sep 6, 2001 after 87 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: 2 generations back to K962823 (1996). 4 ancestors in all.
56 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993762: I.CO.S Screw, New Deal, S.A. (2000) Summary page 1.
- 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
- K050346: Stabilization Screw (2005), 55 descendants of its own
- K071639: Qwix Positioning Screw (2007), 52 descendants of its own
- K091798: Merete Compression Screws (2009), 26 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K131920: Stabilization Screw (2014), 18 descendants of its own

## Indications for use
The “new” 1.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of bone fragments, in long bones or small bones fractures. Fractures management in the foot or hand Arthrodesis in hand, foot or ankle surgery Mono or Bi-corticgl osteotomies in the foot or hand or in long bones Treatment of inferior tibio fibular diastasis The size of the chosen screw should be adapted to the specific indication.

Source page: https://510kreport.com/device/K011821
Methodology: https://510kreport.com/methodology