# K132893: Edge Orthopaedics Bite Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Icon Orthopaedic Concepts Dba Edge Orthopaedics
- Decided: Nov 20, 2013 after 65 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 K810205 (1981). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K080850: Darco Headless Compression Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K100359: Darco Headed Cannulated Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Indications for use
EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only. BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality. Examples of small and long indications for which BITE Compression screws are used: * Minimally invasive fracture/joint reconstructions * Multiple-fragment joint fractures * Simple epiphyseal fractures o Fractures of the head of the humerus o Fractures of the head of the tibia o Cooper fractures of the tibia o Fractures of the radius * Fractures of the wrist, ankle, elbow and shoulder * Scaphoid fractures and other fractures of the hand * Metatarsal fractures and other fracture of the foot * Ligament fixation of the proximal humerus * Ligament avulsion injuries (Apohysis) * Fractures of small joint bones o Maleolar fractures o Navicular fractures * Fractures of the calcancus and talus * Arthrodesis of the ankle joint * Avulsion fracture and metatarsal V * Fractures of the tarsal region * Osteotomies BITE Compression Screws are not intended for use in the spine.

Source page: https://510kreport.com/device/K132893
Methodology: https://510kreport.com/methodology