# K073291: Capstone Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 24, 2008 after 153 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: 9 generations back to K841189 (1984). 27 ancestors in all.
1,103 later devices descend from it; 41 cite it directly.
1 of 1,131 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 2.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 2.

## Most influential descendants
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K094025: Crescent Spinal System (2010), 838 descendants of its own
- K110543: Crescent (R) Spinal System Titanium (2011), 808 descendants of its own
- K090353: Perimeter Interbody Fusion Device (2009), 796 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own

## Indications for use
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD 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 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/K073291
Methodology: https://510kreport.com/methodology