# K040331: Smith and Nephew Titanium Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 14, 2004 after 63 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 K895711 (1990). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895711: Acufex Interference Screw, Sterile, Acufex Microsurgical, Inc. (1990) Summary page 1.
- K900132: Acufex Sterile Cannulated Interference Screw;, Acufex Microsurgical, Inc. (1990) Summary page 1.
- K932027: Oregon Fixation System Interference Screw, Acu Med, Inc. (1994) Summary page 1.
- K921481: Interference-Cannu-Flex/Silk Screws-Screw DR/G Wir, Acufex Microsurgical, Inc. (1993) Summary page 1.

## Most influential descendants
- K083619: Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 (2009), 7 descendants of its own
- K091093: Parcus Ppek CF Interference Screw (2009), 4 descendants of its own
- K180573: Responsive Arthroscopy Interference Screw System (2018), 2 descendants of its own
- K170877: Parcus SLiK Fix Screw (2017), 1 descendant of its own
- K111471: Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) (2011), 1 descendant of its own

## Indications for use
The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Source page: https://510kreport.com/device/K040331
Methodology: https://510kreport.com/methodology