# K160926: F1 MPS Modular Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Jun 28, 2016 after 85 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: 14 generations back to K040583 (2004). 96 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142531: F1-Modular Pedicle Screw System, Degen Medical (2015) Summary page 5.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 5.
- K071860: Modification to: Viper Spine System, Depuy Spine, Inc. (2007) Summary page 5.
- K062196: SFX Snap-Fit Cross Connector, Depuy Spine, Inc. (2006) Summary page 5.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 5.
- K953915: Moss Miami Spinal System (Anterior Use), Depuy, Inc. (1996) Summary page 5.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 5.
- K982511: Depuy Motech Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 5.
- K982011: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998) Summary page 5.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 5.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 5.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 5.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 5.

## Most influential descendants
- K173814: DeGen Medical E3 MIS Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical 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 thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann’s disease; 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 to stabilize the 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/K160926
Methodology: https://510kreport.com/methodology