# K172886: Breakaway Screw System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28
- Decided: Dec 20, 2017 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954385 (1996). 183 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140397: Paralock Plating System / Tuffnek Screw, Paragon 28 (2014) Summary page 5.

## Most influential descendants
- K182148: SILVERBACK Gorilla Plating System (2018), 3 descendants of its own
- K200762: CoLink Cfx Plating System (2020), 1 descendant of its own
- K212640: Stratum® Ankle Fusion Plating System (2021), 0 descendants of its own
- K201149: CoLink Plating System (2020), 0 descendants of its own

## Indications for use
The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

Source page: https://510kreport.com/device/K172886
Methodology: https://510kreport.com/methodology