# K123164: Spinefrontier Pedfuse Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Feb 15, 2013 after 129 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K951116 (1995). 55 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092420: KRD1 Pedicle Screw System, Spinefrontier, Inc. (2009) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.
- K100605: Mis System, Spine Wave, Inc. (2010) Summary page 1.
- K061591: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2006) Summary page 1.

## Most influential descendants
- K133153: Spinefrontier Pedfuse Pedicle Screw System (2014), 1 descendant of its own
- K191655: MEGAFIX® Pedicle Screw Spinal System (2020), 0 descendants of its own
- K143377: PedFuse Pedicle Screw System (2015), 0 descendants of its own

## Recalls of this device
- Mar 5, 2015 · Class II · Z-1479-2015: The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
- Nov 20, 2013 · Class II · Z-0554-2014: Screw inserters may not mate properly with hex interface of the screws.
- Nov 20, 2013 · Class II · Z-0555-2014: Screw inserters may not mate properly with hex interface of the screws.
- Nov 20, 2013 · Class II · Z-0553-2014: Screw inserters may not mate properly with hex interface of the screws.
- Oct 18, 2013 · Class II · Z-0544-2014: During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw.
- Sep 11, 2013 · Class II · Z-0624-2014: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

## Indications for use
The SpineFrontier® PedFuse® Pedicle Screw System 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 (Pseudarthrosis). In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine. When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System 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, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Source page: https://510kreport.com/device/K123164
Methodology: https://510kreport.com/methodology