510(k) · Cleared
ClearedSkyhawk Lateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 2, 2014 as substantially equivalent to K080407 (Blackstone Medical, Inc., 2008) and 4 other predicates after a 149-day review. Its family tree reaches back 8 generations to 1999. 14 later devices descend from it.
- Decided
- Jul 2, 2014
- Review
- 149 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K990745 (1999). 36 ancestors in all, the oldest K962628 (1997). 14 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 1 generation backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- This deviceK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK160362 Z-Span Plate SystemZavation, LLC · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K1721312 Hole Lateral Plating SystemLife Spine, Inc. · 2017 · cites it directly10descendants
- K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018 · 2 generations on9descendants
- K200338ProLift Lateral FixatedLife Spine, Inc. · 2020 · 3 generations on5descendants
- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 4 generations on3descendants
- K160362Z-Span Plate SystemZavation, LLC · 2016 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −1 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| +1 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| +2 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
| +3 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| +4 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +1 | K160362 | Z-Span Plate System | Zavation, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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.
Planning a device in KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K080407 | Blackstone SFS Parallel Rod ConnectorsSummary page 1…tion: Class 11 -21 CFR§ 888.3060 - Spinal Intervertebral Body Fixation Cirthosis Predicate Device: Blackstone Medical Spinal Fixation System (SFS) - K080407 Blackstone Medical Spinal Fixation System (SFS) - K023498 NuVasive La… | 2008 |
| * | K023498 | Modification to Blackstone Spinal Fixation SystemSummary page 1…Predicate Device: Blackstone Medical Spinal Fixation System (SFS) - K080407 Blackstone Medical Spinal Fixation System (SFS) - K023498 NuVasive Lateral Plate System - K091071 NuVasive Lateral Plate System… | 2002 |
| * | K091071 | Nuvasive Lateral Plate SystemSummary page 1…tem (SFS) - K080407 Blackstone Medical Spinal Fixation System (SFS) - K023498 NuVasive Lateral Plate System - K091071 NuVasive Lateral Plate System - K061789 Globus Medical Plymouth Thora… | 2009 |
| * | K061789 | Lateral Plate SystemSummary page 1…pinal Fixation System (SFS) - K023498 NuVasive Lateral Plate System - K091071 NuVasive Lateral Plate System - K061789 Globus Medical Plymouth Thoracolumbar Plate System - K120092 Device Description: The SKY… | 2006 |
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 1…System - K091071 NuVasive Lateral Plate System - K061789 Globus Medical Plymouth Thoracolumbar Plate System - K120092 Device Description: The SKYHAWK Lateral Plate System consists of an assortment of non- s… | 2012 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 36 ancestors have a recall of any class.
- Of its descendants, K172131 (Life Spine, Inc., 2017) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K080407.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications: * Degenerative disc disease (defined as…
Read the full statement (118 words)
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:
* Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
* Spondylolisthesis;
* Spinal stenosis;
* Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
* Tumor;
* Pseudoarthrosis;
* Failed previous fusion; and
* Trauma (i.e., fracture or dislocation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140260: Skyhawk Lateral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140260
Report an extraction error
Are you the manufacturer?
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