# K083096: Latarjet Cortical Screw Set

- Pathway: 510(k) (Traditional)
- Applicant: Tag Medical Products
- Decided: Apr 17, 2009 after 182 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: 1 generation back to K903811 (1990). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903811: Ace Cannulated Cortical Bone Screw, Ace Medical Co. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K892823: Plaster Cutting Scissors, The South India Surgical Co. Pvt., Ltd. (1989). Our reading of the summary gave K892823, FDA’s number for Plaster Cutting Scissors (The South India Surgical Co. Pvt., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes 3mm Cannulated Bone Screw System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K091694: Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM) (2009), 2 descendants of its own
- K110763: Latarjet Cortical Screw Set (2011), 1 descendant of its own
- K253858: GFS - Sterile Screws and Top Hat (2026), 0 descendants of its own
- K240175: Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (2024), 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/K083096
Methodology: https://510kreport.com/methodology