# K191066: CD Horizon™ Astute™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 3, 2019 after 164 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 382 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 404 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182928: CD Horizon™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.
- K172328: SOVEREIGN™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 4.
- K183510: T2 STRATOSPHERE Expandable Corpectomy System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.

## Most influential descendants
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K243007: CD Horizon™ Spinal System (2024), 3 descendants of its own

## Indications for use
The CD HorizonTM AstuteTM Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K191066
Methodology: https://510kreport.com/methodology