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 Feb 17, 2017 as substantially equivalent to K160362 (Zavation, LLC, 2016) and 1 other predicate after a 133-day review. Its family tree reaches back 10 generations to 1999. 2 later devices descend from it.
- Decided
- Feb 17, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K990745 (1999). 43 ancestors in all, the oldest K962628 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 2 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 1 generation backK160362 Z-Span Plate SystemZavation, LLC · 2016
- This deviceK162824 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 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 4 generations backK092108 Truss Thoracolumbar Plate SystemGlobus Medical, Inc. · 2009
- 3 generations backK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- 2 generations backK140260 Skyhawk Lateral Plate SystemOrthofix, Inc. · 2014
- 1 generation backK160362 Z-Span Plate SystemZavation, LLC · 2016
- This deviceK162824 Z-Span Plate SystemZavation, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −4 | K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | 2009 | — |
| −3 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| −2 | K140260 | Skyhawk Lateral Plate System | Orthofix, Inc. | 2014 | — |
| −1 | K160362 | Z-Span Plate System | Zavation, LLC | 2016 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K160362 | Z-Span Plate SystemSummary page 5…sis x Lordotic deformities of the spine x Spinal stenosis x Failed previous spine surgery Predicate Device: Primary: Zavation, Z-Span Plate System (K160362) Additional: Synthes, Antegra-T System (K081568) Technological Characteristics: The technological characteristics including m… | 2016 |
| * | K081568 | Antegra-TSummary page 5…Spinal stenosis x Failed previous spine surgery Predicate Device: Primary: Zavation, Z-Span Plate System (K160362) Additional: Synthes, Antegra-T System (K081568) Technological Characteristics: The technological characteristics including material, design, performance, intended use, and in… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202624 | Z-Span Plate System | 2020 | 1 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K202624 (Zavation Medical Products, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160362.
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. 2017, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162824: 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/K162824
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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