# K092420: KRD1 Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Nov 19, 2009 after 105 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990745 (1999). 13 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K123164: Spinefrontier Pedfuse Pedicle Screw System (2013), 3 descendants of its own
- 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
- K113755: Savannah Technologies Spinal System (2012), 0 descendants of its own

## Recalls of this device
- Mar 14, 2013 · Class II · Z-1926-2013: Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the co
- Dec 30, 2011 · Class II · Z-1737-2013: One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.

## Indications for use
The KRD1TM 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 (Pseudoarthrosis). In addition, the KRD1TM 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.

Source page: https://510kreport.com/device/K092420
Methodology: https://510kreport.com/methodology