# K181625: Life Spine Resolute™ Threaded Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 11, 2018 after 174 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: 11 generations back to K841189 (1984). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112648: Asfora Bullet Cage, Medical Designs, LLC (2012) Summary page 4.
- K090048: Asfora Bullet Cage System, Medical Designs, LLC (2009) Summary page 4.
- K130630: Plateau Spacer System Titanium, Life Spine, Inc. (2013) Summary page 4.
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 4.
- K111569: Plateau Spacer System, Life Spine (2011) Summary page 4.

## Indications for use
The RESOLUTE Threaded Cage System is intended to be used bilaterally 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. The Resolute Threaded Cage System intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K181625
Methodology: https://510kreport.com/methodology