# K994382: Nonlinear Taper Lag Screw

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical
- Decided: Mar 10, 2000 after 73 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 K912598 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970549: Titanium Alloy Bone Screws, Aesculap, Inc. (1997) Summary page 1.

## Indications for use
The Nonlinear Taper Lag Screw is intended for long and small bone fracture fixaticn. This device is not indicated for use in the spine.

Source page: https://510kreport.com/device/K994382
Methodology: https://510kreport.com/methodology