# K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation

- Pathway: 510(k) (Special)
- Applicant: Accel Spine
- Decided: Aug 20, 2013 after 21 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: 6 generations back to K000319 (2000). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113324: Rexious Hook Fixation Systems, Dio Medical Co., Ltd. (2012) Summary page 1.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 1.
- K100765: Fixpine II System, Dio Medical Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K140219: Picasso II Mis Spinal System (2014), 1 descendant of its own
- K173185: SEURAT™ Universal Pedicle Screw System (2018), 0 descendants of its own

## Recalls of this device
- Jul 5, 2018 · Class II · Z-1030-2019: the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the sc
- Jul 5, 2018 · Class II · Z-1031-2019: the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the sc

## Indications for use
The Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Raphael 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 and chronic 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 (pseudarth rosis). The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis trauma(i.e,, fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kylphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.

Source page: https://510kreport.com/device/K132365
Methodology: https://510kreport.com/methodology