# K133577: Clydesdale (R) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 26, 2014 after 309 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: 14 generations back to K841189 (1984). 72 ancestors in all.
256 later devices descend from it; 6 cite it directly.
1 of 329 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.

## Most influential descendants
- K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System (2015), 255 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology (2017), 109 descendants of its own
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (2019), 108 descendants of its own

## Indications for use
The CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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 confirmed by history and radiographic studies. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

Source page: https://510kreport.com/device/K133577
Methodology: https://510kreport.com/methodology