# K223273: ASTRA Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Dec 22, 2022 after 59 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: 21 generations back to K040583 (2004). 421 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 430 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw, Orthofix, Inc. (2018) Summary page 5.
- K150417: Astra Spine System, Spinecraft, LLC (2015) Summary page 5.
- K211323: ASTRA Spine System, Spinecraft, LLC (2021) Summary page 5.
- K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 5.

## Most influential descendants
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K241464: ARx® SAI Implant System (2024), 1 descendant of its own
- K262067: iFuse Granite Onyx™ Implant System (2026), 0 descendants of its own
- K254274: ARx® SAI Implant System (2026), 0 descendants of its own
- K252322: SIros-X System (2025), 0 descendants of its own

## Indications for use
The ASTRA Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The ASTRA Spine System is indicated for non-cervical (T1-S2/1lium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra:; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture and/or dislocation); spinal stenosis; deformities (scoliosis, lordosis and/or kyphosis); spinal tumor; and failed previous fusion (pseudo-arthrosis). When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD - defined as discogenic back pain 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, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The ASTRA fenestrated screw when used with other components of the ASTRA Spine System is indicated to provide the surgeon with an open or minimally invasive approach for posterior spinal surgery. The ASTRA fenestrated screw is intended to be used with saline or radiopaque dye.

Source page: https://510kreport.com/device/K223273
Methodology: https://510kreport.com/methodology