# K150693: PHIN-FX Cannulated Lag Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Medical, LLC
- Decided: Oct 13, 2015 after 209 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: 11 generations back to K962616 (1996). 104 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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) Summary page 4.
- 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 4.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 4.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 4.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 4.
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 4.
- K142442: Magna-FX and Mini Magna-FX Cannulated Screw Fixation System, Zimmer, Inc. (2014) Summary page 4.
- K120493: Mini Cannulated Headed and Headless Screw Set, Instratek, Inc. (2012) Summary page 4.
- K123890: Acumed Cannulated Screw System, Acumed, LLC (2013) Summary page 4.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 4.

## Most influential descendants
- K161904: GEO Bone Screw System (2017), 4 descendants of its own
- K163489: OrthoSolutions 'System26' Bone Screws (2017), 3 descendants of its own
- K203773: BRM TOOL Screws (2022), 1 descendant of its own
- K202817: GEO Bone Screw System (2020), 1 descendant of its own
- K201430: InFrame™ Cannulated Fixation System (2020), 1 descendant of its own

## Indications for use
The intended use of the Ascent Medical – PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient. The Ascent Medical – PHIN-FX Cannulated Lag Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows: The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna, olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication. The Large – PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication. The Ascent Medical – PHIN-FX Cannulated Lag Screw System is not for spinal use.

Source page: https://510kreport.com/device/K150693
Methodology: https://510kreport.com/methodology