# K121760: Capstone Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Aug 29, 2012 after 75 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: 12 generations back to K841189 (1984). 60 ancestors in all.
723 later devices descend from it; 8 cite it directly.
1 of 784 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.
- K103731: Capstone R Spinal System, Medtronic Sofamor Danek (2011) Summary page 2.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 2.
- K110543: Crescent (R) Spinal System Titanium, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.

## Most influential descendants
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- 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

## Indications for use
The CAPSTONE® Spinal System is indicated for interbody fuision with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to SI. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DD 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 non-operative treatment. 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/K121760
Methodology: https://510kreport.com/methodology