510(k) · Cleared
ClearedZION Anterior Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 23, 2016 as substantially equivalent to K132012 (Zimmer Spine, Inc., 2013) and 6 other predicates after a 162-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 23, 2016
- Review
- 162 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K953730 (1995). 26 ancestors in all, the oldest K914362 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 3 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 2 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 1 generation backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- This deviceK160702 ZION Anterior Cervical Fixation SystemAstura Medical · 2016
- Descendant · cites it directly · 0 of its ownK250446 Frida™ Anterior Cervical Plate SystemSpineup, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK213456 Xenco Medical Multilevel CerviKitXenco Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK192494 NexGen Anterior Cervical Plate SystemPrecision Spine · 2019
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 |
|---|---|---|---|---|---|
| −5 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −3 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −2 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| 0 (this device) | K160702 | ZION Anterior Cervical Fixation System | Astura Medical | 2016 | — |
| +1 | K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025 | — |
| +1 | K213456 | Xenco Medical Multilevel CerviKit | Xenco Medical, LLC | 2021 | — |
| +1 | K192494 | NexGen Anterior Cervical Plate System | Precision Spine | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K132012 | Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Summary page 4…21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Zimmer Trinica/Trinica Select Anterior Cervical Plate (K132012) Device Spinal USA Slimpicity Anterior Cervical Plating System (K060025) Secondary Predicate Biome… | 2013 |
| * | K060025 | Slimplicity Anterior Cervical Plate SystemSummary page 4…Zimmer Trinica/Trinica Select Anterior Cervical Plate (K132012) Device Spinal USA Slimpicity Anterior Cervical Plating System (K060025) Secondary Predicate Biomet C-TekV MaxAnrm Anterior Cervical Plate System (K080646) Devices Synthes CLSP Ce… | 2006 |
| * | K080646 | C-Tek Maxan Anterior Cervical Plate SystemSummary page 4…Spinal USA Slimpicity Anterior Cervical Plating System (K060025) Secondary Predicate Biomet C-TekV MaxAnrm Anterior Cervical Plate System (K080646) Devices Synthes CLSP Cervical Plate (K000536) DePuy UNIPLATE Anterior Cervical Plate (… | 2008 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 4…al Plating System (K060025) Secondary Predicate Biomet C-TekV MaxAnrm Anterior Cervical Plate System (K080646) Devices Synthes CLSP Cervical Plate (K000536) DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) The Astu… | 2000 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 4…Anterior Cervical Plate System (K080646) Devices Synthes CLSP Cervical Plate (K000536) DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) The Astura Medical ZION Anterior Cervical Fixation System is intended for… | 2004 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 4…Cervical Plate System (K080646) Devices Synthes CLSP Cervical Plate (K000536) DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) The Astura Medical ZION Anterior Cervical Fixation System is intended for… | 2008 |
| * | K100070 | Uniplate Anterior Cervical Plate SystemSummary page 4…late System (K080646) Devices Synthes CLSP Cervical Plate (K000536) DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) The Astura Medical ZION Anterior Cervical Fixation System is intended for ant… | 2010 |
What descends from it? (3)
3 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 21 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K250446 (Spineup, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132012.
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 ZION Anterior Cervical Fixation System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration…
Read the full statement (113 words)
The ZION Anterior Cervical Fixation System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.
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/K160702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160702: ZION Anterior Cervical Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160702
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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