# K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer

- Pathway: 510(k) (Special)
- Applicant: Interventional Spine, Inc.
- Decided: Jun 11, 2009 after 80 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: 4 generations back to K020411 (2002). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082795: Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant, Interventional Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K101762: Viper F2 Facet Fixation System (2010), 1 descendant of its own
- 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
- K110170: Raptor Facet Fixation System (2011), 0 descendants of its own

## Indications for use
The PERPOSTM FCD-2 is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin, as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion. The intended use of the PERPOS M T FCD-2 is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The PERPOSTM FCD-2 is intended for lumbar bilateral facet fixation, with bone graft, at single or multiple levels from Li to SI. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOSTM FCD-2 Anchor and Stabilizer.

Source page: https://510kreport.com/device/K090767
Methodology: https://510kreport.com/methodology