# K123978: Capstone L Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA
- Decided: Apr 9, 2013 after 104 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). 43 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K112405: Clydesdales Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K113528: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K122591: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2012) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K133645: Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter Spinal System (2014), 6 descendants of its own
- K203038: Toro-L Interbody Fusion System (2021), 5 descendants of its own
- K213355: Toro-L Interbody Fusion System (2022), 4 descendants of its own
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (2020), 4 descendants of its own
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (2023), 2 descendants of its own

## Indications for use
The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmned 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 a minimally invasive lateral approach.

Source page: https://510kreport.com/device/K123978
Methodology: https://510kreport.com/methodology