# K101762: Viper F2 Facet Fixation System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Nov 15, 2010 after 146 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K020411 (2002). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer, Interventional Spine, Inc. (2009) Summary page 1.
- K092464: Spineology Facet Screw, Spineology, Inc. (2009) Summary page 1.
- K061041: US Spine Facet Fixation System, Us Spine (2006) Summary page 1.
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 1.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K192281: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (2019), 0 descendants of its own

## Indications for use
The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only: Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. This system is indicated for the posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K101762
Methodology: https://510kreport.com/methodology