# K153446: OLYMPIC Posterior Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Apr 8, 2016 after 133 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181139: OLYMPIC Posterior Spinal Fixation System (2018), 8 descendants of its own
- K230245: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (2023), 3 descendants of its own
- K231694: MASADA Modular Spinal Fixation System (2023), 2 descendants of its own
- K231636: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (2023), 2 descendants of its own
- K232311: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (2023), 1 descendant of its own

## Indications for use
The OLYMPIC Posterior Spinal Fixation 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 thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft. In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K153446
Methodology: https://510kreport.com/methodology