510(k) · Cleared
ClearedSkyhawk Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 27, 2014 as substantially equivalent to K103111 (Orthofix, Inc., 2011) and 2 other predicates after a 67-day review. Its family tree reaches back 14 generations to 1984. 1 of the 65 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 27, 2014
- Review
- 67 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K841189 (1984). 57 ancestors in all. 7 later devices descend from it, 1 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 2 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 1 generation backK131669 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140709 Skyhawk Interbody Fusion SystemOrthofix, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK162446 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK…Orthofix, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System…Orthofix, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK213951 FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022
- Descendant · 4 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 3 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 2 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 1 generation backK131669 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140709 Skyhawk Interbody Fusion SystemOrthofix, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 7 · See all- K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc. · 2016 · cites it directly6descendants
- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc. · 2021 · 2 generations on5descendants
- K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022 · 3 generations on4descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 4 generations on2descendants
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −3 | K111525 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2011 | — |
| −2 | K113642 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek USA | 2012 | — |
| −1 | K131669 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K140709 | Skyhawk Interbody Fusion System | Orthofix, Inc. | 2014 | — |
| +1 | K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System… | Orthofix, Inc. | 2016 | — |
| +2 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini… | Orthofix, Inc. | 2021 | — |
| +3 | K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | 2022 | — |
| +4 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +5 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 1 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103111 | Forza Spacer SystemSummary page 1…MAX Classification: Class 11 -21 CFR § 888.3080 - Intervertebral Body Fusion Device Predicate Device: Orthofix FORZA Spacer System - K 1031 11 NuVasive CoRoent System - K07 1795 Medtronic PERIMETER Interbody Fusi… | 2011 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1….3080 - Intervertebral Body Fusion Device Predicate Device: Orthofix FORZA Spacer System - K 1031 11 NuVasive CoRoent System - K07 1795 Medtronic PERIMETER Interbody Fusion Device - K 131669 Device Description: The SKYHAWK I… | 2007 |
| * | K131669 | Perimeter Interbody Fusion DeviceSummary page 1…ZA Spacer System - K 1031 11 NuVasive CoRoent System - K07 1795 Medtronic PERIMETER Interbody Fusion Device - K 131669 Device Description: The SKYHAWK Interbody Fusion System consists of implants, trials, and… | 2013 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK… | 2016 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 57 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K162446 (Orthofix, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K103111.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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…
Read the full statement (146 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140709: Skyhawk Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140709
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026