# K073531: Accin Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Innovation, LLC
- Decided: Feb 4, 2008 after 49 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 8 generations back to K951116 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033352: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2004) Summary page 1.
- K043152: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K051716: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K071376: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2007) Summary page 1.

## Indications for use
The AccinTM Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of: * Degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis (grade 3 or 4) * Trauma (i.e.: fracture or dislocation) * Spinal stenosis * Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion. The AccinTM Pedicle Screw System components are intended for non-cervical pedicle fixation of: * Spondylolisthesis (grade 3 or 4) * Trauma (i.e.: fracture or dislocation) * Spinal stenosis * Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis Failed previous fusion. These components are single use only and are intended for use in skeletally mature patients.

Source page: https://510kreport.com/device/K073531
Methodology: https://510kreport.com/methodology