# K031455: Conklusion Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medical, LLC
- Decided: Oct 22, 2003 after 168 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992147 (2000). 3 ancestors in all.
179 later devices descend from it; 1 cites it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022271: Plus Pivot Link Universal System, Spine Vision, Inc. (2002) Summary page 1.
- K001668: Global Spinal Fixation System, D.K.M. Co., Ltd. (2000)
- K992147: Triple-Fix Spinal Fixation System, Advanced Spine Technology, Inc. (2000) Summary page 1.

## Most influential descendants
- K070933: Lowtop Pedicle Screw System (2007), 178 descendants of its own
- K072187: Pioneer Lowtop Spinal Rod System (2007), 177 descendants of its own
- K080518: Pioneer Surgical Technology Quantum Spinal System (2008), 174 descendants of its own
- K100297: Pass LP Spinal System (2010), 136 descendants of its own
- K110497: Pass LP Spinal System (2011), 133 descendants of its own

## Indications for use
The Conklusion Pedicle Screw System, including hooks, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K031455
Methodology: https://510kreport.com/methodology