# K142531: F1-Modular Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Mar 20, 2015 after 192 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 13 generations back to K040583 (2004). 74 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130646: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.

## Most influential descendants
- K160926: F1 MPS Modular Pedicle Screw System (2016), 1 descendant of its own
- K173814: DeGen Medical E3 MIS Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann’s disease, and failed previous fusion. The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K142531
Methodology: https://510kreport.com/methodology