510(k) Report

510(k) · Cleared

Cleared

Zavation Cervical Plate System

K112533510(k) TraditionalCleared Dec 8, 2011101-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zavation, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 8, 2011 as substantially equivalent to K993066 (Advanced Spine Technology, Inc., 2000) and 2 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1997. 26 later devices descend from it.

Decided
Dec 8, 2011
Review
101 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K971730 (1997). 9 ancestors in all, the oldest K953730 (1995). 26 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1998: 1 other ancestor2018: 5 descendants cleared2015: 2 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2023: 4 descendants cleared2024: 4 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 2 descendants clearedK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997K013439 · Anterior Cervical Plate System · Scien'Tx USA, Inc. · 2002K042317 · Cervical Plate · Scient'X · 2004K070681 · Next Generation Anterior Cervical Plating System · Alphatec Spine, Inc. · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K070681 · Next Generation Anterior Cervical Plating System · Alphatec Spine, Inc. · 2007 · recalledK042317 · Cervical Plate · Scient'X · 2004K013439 · Anterior Cervical Plate System · Scien'Tx USA, Inc. · 2002K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970+5
  1. Root · 4 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 3 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
  3. 2 generations backK042317 Cervical PlateScient'X · 2004
  4. 1 generation backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
  5. This deviceK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
  6. Descendant · cites it directly · 15 of its ownK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
  7. Descendant · cites it directly · 7 of its ownK181244 Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018
  8. Descendant · 2 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
  9. Descendant · 2 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
  10. Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2013: 12015: 22017: 12018: 52020: 32022: 22023: 42024: 42025: 22026: 2
2013high 5 (2018) · low 0 (2014)2026

Most influential descendants

Showing 5 of 26 · See all
  • K130030Zavation Cervical Plate SystemZavation, LLC · 2013 · cites it directly15descendants
  • K181244Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018 · cites it directly7descendants
  • K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 2 generations on6descendants
  • K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 2 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−3K013439Anterior Cervical Plate SystemScien'Tx USA, Inc.2002—
−2K042317Cervical PlateScient'X2004—
−1K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.20071
0 (this device)K112533Zavation Cervical Plate SystemZavation, LLC2011—
+1K130030Zavation Cervical Plate SystemZavation, LLC2013—
+1K181244Zavation Cervical Plate SystemZavation Medical Products, LLC2018—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC2022—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.2017—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201520
201710
201850
202030
202220
202340
202440
202520
202620
FIG. 1 — Lineage of K112533, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K993066Window Cervical Dynamic Plate System
Summary page 2
…Zavation Cervical Plate System components are manufactured from titanium alloy (Ti-6A- 4V) as described by ASTM F136. Predicate Device: Window Cervical Plate System (K(993066) Trestle Alphatec Spine (K(070681) Slim-boc Depuy Spine (1(013877) Technological Characteristics: The Zavation Cervical Plate Sy…
Advanced Spine Technology, Inc.2000—
*K070681Next Generation Anterior Cervical Plating System
Summary page 2
…mponents are manufactured from titanium alloy (Ti-6A- 4V) as described by ASTM F136. Predicate Device: Window Cervical Plate System (K(993066) Trestle Alphatec Spine (K(070681) Slim-boc Depuy Spine (1(013877) Technological Characteristics: The Zavation Cervical Plate System possesses the same technologi…
Alphatec Spine, Inc.20071
*K013877Codman Slim-Loc System
Summary page 2
…itanium alloy (Ti-6A- 4V) as described by ASTM F136. Predicate Device: Window Cervical Plate System (K(993066) Trestle Alphatec Spine (K(070681) Slim-boc Depuy Spine (1(013877) Technological Characteristics: The Zavation Cervical Plate System possesses the same technological characteristics as the predi…
Codman & Shurtleff, Inc.2001—

What descends from it? (26)

See all 26

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130030Zavation Cervical Plate SystemZavation, LLC201315
K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187
K150666uNion Cervical Plate SystemUlrich Medical USA20153
K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180
K173306EZ PlateZavation Medical Products, LLC20180

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 14 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K130030 (Zavation, LLC, 2013) has gone furthest, with 15 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmied by history and radiographic studies), spondylohisthesis, traumna (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordlosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Indications for use as stated in the FDA summary.

More from Zavation, LLC

15 FDA decisions under this applicant name. See the company

  • K162206Zavation IBFZavation, LLC · 2017
  • K162575Z-LINKPC SystemZavation, LLC · 2017
  • K162824Z-Span Plate SystemZavation, LLC · 2017
  • K161016Z-Clamp ISP SystemZavation, LLC · 2016
  • K153404Zavation Spinal SystemZavation, LLC · 2016

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K112533 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112533: Zavation Cervical 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/K112533

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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