# K181139: OLYMPIC Posterior Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: Jul 6, 2018 after 67 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: 17 generations back to K040583 (2004). 278 ancestors in all.
8 later devices descend from it; 4 cite it directly.
1 of 287 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153446: OLYMPIC Posterior Spinal Fixation System, Astura Medical (2016) Summary page 4.
- K143633: CREO Stabilization System, Globus Medical, Inc. (2015) Summary page 4.
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 4.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 4.
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 4.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 4.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 4.
- K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 4.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 4.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 4.
- K111358: Synthes Uss, Synthes Spine (2011) Summary page 4.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 4.
- K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 4.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 4.
- K920116: PWB Lumbosacral Spine System, Cross Medical Products, Inc. (1992) Summary page 4.
- K090390: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 4.
- K162494: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.
- K162379: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K261130: AccelFix Spinal Fixation System (2026), 0 descendants 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 and non-pedicle fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle and non-pedicle fixation in pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle and non-pedicle fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K181139
Methodology: https://510kreport.com/methodology