# K231819: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

- Pathway: 510(k) (Traditional)
- Applicant: Innovate Orthopaedics Limited
- Decided: Sep 5, 2023 after 76 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: 4 generations back to K915424 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212547: Quick-Start Screws, Innovate Orthopaedics Limited (2021) Summary page 4.

## Most influential descendants
- K242442: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (2025), 0 descendants of its own

## Indications for use
Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone 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/K231819
Methodology: https://510kreport.com/methodology