# K200937: ACURA Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Indius Medical Technologies Pvt., Ltd.
- Decided: Oct 26, 2020 after 201 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: 18 generations back to K040583 (2004). 354 ancestors in all.
No later device cites it as a predicate yet.
1 of 355 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 5.
- K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 5.
- K193365: M.U.S.T. Pedicle Screw System, Medacta International S.A. (2020) Summary page 5.
- K180458: FOCUS Pedicle Screw System, Nvision Biomedical Technologies, LLC (2018) Summary page 6.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 6.
- K180210: CREO® Stabilization System, Globus Medical, Inc. (2018) Summary page 6.
- K133350: Revere Stabilization System, Globus Medical, Inc. (2014) Summary page 6.

## Indications for use
ACURA Stabilization System is intended to help provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. Degenerative spondylolisthesis 3. Trauma (fracture or dislocation) 4. Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann’s disease) 5. Spinal tumours 6. Spinal Stenosis 7. Pseudarthrosis 8. Previous Failed Fusions When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K200937
Methodology: https://510kreport.com/methodology