# K123027: Capstone (R) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 25, 2013 after 300 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 71 ancestors in all.
709 later devices descend from it; 13 cite it directly.
1 of 781 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 2.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 2.
- K103731: Capstone R Spinal System, Medtronic Sofamor Danek (2011) Summary page 2.
- K082732: Modification to: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own
- K152304: Tritanium PL Cage (2015), 448 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (ODD) at one or two levels from L2 to St. These DOD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. ODD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Additionally, the CAPSTONE® Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw Fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental Fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K123027
Methodology: https://510kreport.com/methodology