# K172816: TiGer Shark™ System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Jan 26, 2018 after 130 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: 20 generations back to K841189 (1984). 203 ancestors in all.
59 later devices descend from it; 9 cite it directly.
1 of 263 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120991: TRANS1 Interbody Fusion System, Trans1 Incorporated (2012) Summary page 5.
- K142277: Juliet PO, Spineart (2014) Summary page 5.
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™), Choicespine, LP (2016) Summary page 5.

## Most influential descendants
- K201671: A-Link Z (2021), 25 descendants of its own
- K183397: ChoiceSpine Stealth Cervical Spacer System (2019), 16 descendants of its own
- K222561: Align (2022), 14 descendants of its own
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K232432: E3D™-A Interbody System (2024), 8 descendants of its own

## Indications for use
The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K172816
Methodology: https://510kreport.com/methodology