# K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Nov 23, 2016 after 117 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: 19 generations back to K841189 (1984). 196 ancestors in all.
161 later devices descend from it; 2 cite it directly.
1 of 358 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140142: Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choicespine, LP (2014) Summary page 4.
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System, Choicespine, LP (2016) Summary page 4.
- K120991: TRANS1 Interbody Fusion System, Trans1 Incorporated (2012) Summary page 4.
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, Ldr Spine USA (2016) Summary page 6.

## Most influential descendants
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own

## Indications for use
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™): The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™): The Choice Spine Interbody Fusion 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 months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine. Choice Spine Vertebral Body Replacement System (Hawkeye™): The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Vertebral Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion

Source page: https://510kreport.com/device/K162103
Methodology: https://510kreport.com/methodology