# K003496: Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Feb 8, 2001 after 87 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
345 later devices descend from it; 6 cite it directly.
1 of 346 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer Magna-FX: named in the summary without a submission number
- (no number) ZIMMER Mini MAGNA-FX: named in the summary without a submission number
- (no number) Synthes Cannulated Screw System: named in the summary without a submission number

## Most influential descendants
- K102903: Pioneer Cannulated Screw System (2010), 309 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K112885: Zimmer Plates and Screws System Screws Only (2011), 135 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

## Recalls of this device
- Mar 3, 2006 · Not classified · Z-0872-06: There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than int

## 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: 1. Fractures of the tarsals and metatarsals; 2. Metatarsal and phalangeal osteotomies; 3. Fractures of the carpals and metacarpals; 4. Carpal and metacarpal arthrodesis; 5. Small fragments of the hand and wrist; 6. Ligament fixation as appropriate; 7. Sacroiliac joint disruptions; 8. Fractures of the distal femur and proximal tibia; 9. Intracapsular fractures of the hip; 10. Ankle arthrodesis; and 11. Pelvis and acetabulum fractures; 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/K003496
Methodology: https://510kreport.com/methodology