# K211323: ASTRA Spine System

- Pathway: 510(k) (Special)
- Applicant: Spinecraft, LLC
- Decided: Jun 3, 2021 after 34 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). 370 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 383 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150417: Astra Spine System, Spinecraft, LLC (2015) Summary page 4.
- K202771: CD Horizon Spinal System, Medtronic (2020) Summary page 4.
- K160904: Expedium Spine System, VIPER and VIPER 2 Systems, Medos International SARL (2016) Summary page 4.

## Most influential descendants
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K221776: NextGen Pedicle Screw System (2022), 2 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

## 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 the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudo-arthrosis). The ASTRA Spine System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed 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 (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.

Source page: https://510kreport.com/device/K211323
Methodology: https://510kreport.com/methodology