# K992106: Modus System Self-Drilling Screws

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Sep 17, 1999 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: 3 generations back to K761228 (1976). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System, Elekta Instruments, Inc. (1995) Summary page 1.
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 1.
- K970912: Leibinger Self-Drilling Screw, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K974017: Timesh System, Sofamor Danek USA,Inc. (1998). Our OCR of the scanned summary read K974107, FDA’s number for Kodak Digital Science Quality Control Workstation (QCW) (Eastman Kodak Company). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TIMESH System Screws”.
- (no number) Lorenz Self-Drilling Screw: named in the summary without a submission number

## Indications for use
The MODUS System Self-drilling Screws are intended for use in the internal fixation in osteotomies and fractures of the craniofacial skeleton which require positional and functional stability.

Source page: https://510kreport.com/device/K992106
Methodology: https://510kreport.com/methodology