# K120493: Mini Cannulated Headed and Headless Screw Set

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: May 17, 2012 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962823 (1996). 37 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 1.
- K010783: 2.0/2.4 Cannulated Screw System, Osteomed Corp. (2001) Summary page 1.
- K060026: Koby Surgical Internal Fixation System, Koby Surgical (2006) Summary page 1.
- K101030: Modification to HBS Headless Bone Screw, Biopro, Inc. (2010) Summary page 1.
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 1.
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Vilex, Inc. (1998) Summary page 1.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999)
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 1.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 1.
- K960537: K2 Bone Screw System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K960533: K3 Bone Screw System, Kinetikos Medical, Inc. (1996) Summary page 1.
- K950704: K4 Bone Screw System, Kinetikos Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own

## Recalls of this device
- Apr 25, 2013 · Class II · Z-2679-2014: Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

## Indications for use
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine. The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications: * Scaphoid Fractures * Capitate * Metacarpal Fractures * Phalangeal Fractures * Ulnar Styloid Fractures * Small Joint Fusion * Humeral head Fractures * Intercarpal Fractures * Tarsal Fusions * Patellar Fractures * lnterfragmentary Ulnar Fractures * Small Hand and Wrist Bone Fractures * Forefoot Interfragmentary Fractures * Lunate Fractures * Trapezial Fractures * Metatarsal Fractures * Radial Head Fractures * ste-Chondral * Ostero-Chondral Fractures * Glenoid Fractrures; * Interphalangeal Fractures * Malleolar Fractures * Metaphyseal Fratures * Interfragmentary Radius Fractures * Distal Metatarsal Osteotomies * Midfoot lnterfragmentary Fractures

Source page: https://510kreport.com/device/K120493
Methodology: https://510kreport.com/methodology