# K220953: ChoiceSpine TigerShark™ M, Modular Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: Sep 13, 2022 after 165 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: 21 generations back to K841189 (1984). 215 ancestors in all.
No later device cites it as a predicate yet.
1 of 216 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123607: Octane Elevate Spinal Implant System, Exactech, Inc. (2014) Summary page 5.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 5.

## Indications for use
The ChoiceSpine TigerShark™ M, Modular Interbody System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The device system is designed for use with autograft bone and/or allogenic bone grafts composed of cancellous and /or corticocancellous bone grafts, and with supplemental internal fixation systems (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K220953
Methodology: https://510kreport.com/methodology