# K242442: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

- Pathway: 510(k) (Traditional)
- Applicant: Innovate Orthopaedics, Ltd.
- Decided: Jan 31, 2025 after 168 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: 5 generations back to K915424 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231819: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw, Innovate Orthopaedics Limited (2023) Summary page 5.

## Indications for use
Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.

Source page: https://510kreport.com/device/K242442
Methodology: https://510kreport.com/methodology