# K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Oct 21, 2025 after 85 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: 20 generations back to K040583 (2004). 606 ancestors in all.
No later device cites it as a predicate yet.
1 of 607 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231694: MASADA Modular Spinal Fixation System, Astura Medical (2023) Summary page 7.
- K182239: OLYMPIC Posterior Spinal Fixation System, Astura Medical, LLC (2018) Summary page 7.
- K222774: iFuse Bedrock Granite® Implant System, SI-BONE, Inc. (2022) Summary page 7.
- K232211: REUNION Sacroiliac Joint Fusion System, Astura Medical (2023) Summary page 7.

## Indications for use
Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: 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, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. 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. Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: -Spinal trauma surgery, used in sublaminar or facet wiring techniques. -Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. -Spinal degenerative surgery, as an adjunct to spinal fusions. The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants. S2Al Screws: The OLYMPIC Posterior Spinal Fixation System S2Al Screw System is intended for sacroiliac joint fusion for the following conditions: « Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacrolliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. » To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. * Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. When connected to OLYMPIC posterior rods the OLYMPIC S2Al Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies » Spondylolisthesis » Trauma (i.e., fracture or dislocation) » Spinal stenosis » Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis) * Spinal tumor * Pseudarthrosis * Failed previous fusion Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments. Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immmobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: 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, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants. S2Al Screws: The MASADA Modular Spinal Fixation System S2Al Screw System is intended for sacroiliac joint fusion for the following conditions: « Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. » To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. » Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. When connected to MASADA posterior rods the MASADA S2AIl Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies » Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Spinal stenosis » Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis) * Spinal tumor * Pseudarthrosis * Failed previous fusion Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Source page: https://510kreport.com/device/K252346
Methodology: https://510kreport.com/methodology