# K102903: Pioneer Cannulated Screw System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Oct 20, 2010 after 20 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: 1 generation back to K962011 (1996). 3 ancestors in all.
309 later devices descend from it; 10 cite it directly.
1 of 313 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K131405: Ifuse Implant System (2013), 133 descendants of its own
- K110472: SI-Fix Sacroiliac Joint Fusion System (2012), 92 descendants of its own
- K141049: Ifuse Implant System (2014), 88 descendants of its own
- K150875: iFuse Implant System (2015), 86 descendants of its own

## Indications for use
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following: Fractures of the tarsals and metatarsals; Metatarsal and phalangeal osteotomies; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Small fragments of the hand and wrist; Ligament fixation, if appropriate; Sacroiliac joint disruptions; Fractures of the distal femur and proximal tibia; Intracapsular fractures of the hip; Ankle arthrodesis; and Pelvis and acetabulum fractures; and Areas where accurate screw placement Is vital. This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.

Source page: https://510kreport.com/device/K102903
Methodology: https://510kreport.com/methodology