# K031751: Rapidfire Self Drilling Screws

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Jun 26, 2003 after 21 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 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)
- K013954: Lorenz Self Drilling Screws, Walter Lorenz Surgical, Inc. (2002)

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0626-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Indications for use
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

Source page: https://510kreport.com/device/K031751
Methodology: https://510kreport.com/methodology