510(k) · Cleared
ClearedZ-Span Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 22, 2016 as substantially equivalent to K063158 (Synthes Spine Co.Lp, 2006) and 1 other predicate after a 42-day review. Its family tree reaches back 9 generations to 1999. 3 later devices descend from it.
- Decided
- Mar 22, 2016
- Review
- 42 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K990745 (1999). 39 ancestors in all, the oldest K962628 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 2 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 1 generation backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- This deviceK160362 Z-Span Plate SystemZavation, LLC · 2016
- Descendant · cites it directly · 2 of its ownK162824 Z-Span Plate SystemZavation, LLC · 2017
- Descendant · cites it directly · 1 of its ownK202624 Z-Span Plate SystemZavation Medical Products, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK230721 ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 2 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 1 generation backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- This deviceK160362 Z-Span Plate SystemZavation, LLC · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −2 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −1 | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| 0 (this device) | K160362 | Z-Span Plate System | Zavation, LLC | 2016 | — |
| +1 | K162824 | Z-Span Plate System | Zavation, LLC | 2017 | — |
| +1 | K202624 | Z-Span Plate System | Zavation Medical Products, LLC | 2020 | — |
| +2 | K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023 | — |
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 | 7 | 0 |
| 2003 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K063158 | Synthes Antegra SystemSummary page 5…Scoliosis • Lordotic deformities of the spine • Spinal stenosis • Failed previous spine surgery Predicate Device: Primary: Synthes, Antegra System (K063158) Additional: Orthofix, Skyhawk Plate System (K140260) Technological Characteristics: The technological characteristics includi… | 2006 |
| * | K140260 | Skyhawk Lateral Plate SystemSummary page 5…Spinal stenosis • Failed previous spine surgery Predicate Device: Primary: Synthes, Antegra System (K063158) Additional: Orthofix, Skyhawk Plate System (K140260) Technological Characteristics: The technological characteristics including material, design and performance of the Z-Span Plate… | 2014 |
What descends from it? (3)
2 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 17 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K162824 (Zavation, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K063158.
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. 2016, 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 Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1). The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the…
Read the full statement (131 words)
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).
The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:
• Fracture (including dislocation and subluxation)
• Tumor
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Pseudoarthrosis
• Spondylolysis
• Spondylolisthesis
• Scoliosis
• Lordotic deformities of the spine
• Spinal stenosis
• Failed previous spine surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160362: Z-Span Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160362
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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