# K140709: Skyhawk Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 27, 2014 after 67 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: 14 generations back to K841189 (1984). 57 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103111: Forza Spacer System, Orthofix, Inc. (2011) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K131669: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K162446: FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System (2016), 6 descendants of its own
- K211704: CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (2021), 5 descendants of its own
- K213951: FORZA XP Expandable Spacer System (2022), 4 descendants of its own
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), 2 descendants of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own

## Indications for use
The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the SKYHAWK Interbody Fusion System.

Source page: https://510kreport.com/device/K140709
Methodology: https://510kreport.com/methodology