# K091694: Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)

- Pathway: 510(k) (Special)
- Applicant: Tag Medical Products
- Decided: Jul 7, 2009 after 27 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903811 (1990). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083096: Latarjet Cortical Screw Set, Tag Medical Products (2009) Summary page 1.

## Most influential descendants
- K110763: Latarjet Cortical Screw Set (2011), 1 descendant of its own
- K253858: GFS - Sterile Screws and Top Hat (2026), 0 descendants of its own

## Recalls of this device
- May 12, 2017 · Class II · Z-2618-2017: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- May 12, 2017 · Class II · Z-2615-2017: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- May 12, 2017 · Class II · Z-2619-2017: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- May 12, 2017 · Class II · Z-2616-2017: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
- May 12, 2017 · Class II · Z-2617-2017: Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

## Indications for use
The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

Source page: https://510kreport.com/device/K091694
Methodology: https://510kreport.com/methodology