# K191834: Stand-Alone ALIF Titanium System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 16, 2019 after 160 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: 20 generations back to K841189 (1984). 228 ancestors in all.
No later device cites it as a predicate yet.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180215: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System, Life Spine, Inc. (2018) Summary page 4.
- K091301: Life Spine Stand-Alone Spacer System, Life Spine (2009) Summary page 4.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 4.

## Indications for use
The Stand-Alone ALIF Titanium 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 allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).

Source page: https://510kreport.com/device/K191834
Methodology: https://510kreport.com/methodology