# K142559: ELEVATE Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 9, 2015 after 271 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: 15 generations back to K003155 (2001). 131 ancestors in all.
130 later devices descend from it; 7 cite it directly.
1 of 262 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 4.
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 5.
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 5.
- K121333: Wave D Cage, Advanced Medical Technologies AG (2012) Summary page 5.

## Most influential descendants
- K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments (2017), 103 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own

## Indications for use
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion 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. 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/K142559
Methodology: https://510kreport.com/methodology