# K180215: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Sep 13, 2018 after 231 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 17 generations back to K841189 (1984). 98 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091301: Life Spine Stand-Alone Spacer System, Life Spine (2009) Summary page 4.
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 4.

## Most influential descendants
- K191834: Stand-Alone ALIF Titanium System (2019), 0 descendants of its own
- K192054: Endoskeleton TAS Plate (2019), 0 descendants of its own

## Indications for use
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft. The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.

Source page: https://510kreport.com/device/K180215
Methodology: https://510kreport.com/methodology