# K082795: Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant

- Pathway: 510(k) (Traditional)
- Applicant: Interventional Spine, Inc.
- Decided: Dec 12, 2008 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: 3 generations back to K020411 (2002). 7 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062391: Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00, Triage Medical, Inc. (2006) Summary page 1.
- K043351: 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N, Triage Medical, Inc. (2005) Summary page 1.
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.

## Most influential descendants
- K102438: Primalok Facet Fixation System (2010), 4 descendants of its own
- K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer (2009), 3 descendants of its own
- K240085: zLOCK Lumbar Facet Fixation System (2024), 2 descendants of its own
- K101762: Viper F2 Facet Fixation System (2010), 1 descendant of its own
- K242527: The Karma® Fixation System (2025), 0 descendants of its own

## Indications for use
The 4.5mm BONE-LOK® PLS IMPLANT 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 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant 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 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

Source page: https://510kreport.com/device/K082795
Methodology: https://510kreport.com/methodology