510(k) Report

510(k) · Cleared

Cleared

Cardiff Anterior Cervical Plate System

K083338510(k) TraditionalCleared Feb 2, 200982-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

Seaspine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 2, 2009 as substantially equivalent to K032368 (Seaspine, 2003) and 5 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1993. 16 later devices descend from it.

Decided
Feb 2, 2009
Review
82 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K926453 (1993). 6 ancestors in all. 16 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor1995: 1 other ancestor2012: 1 descendant cleared2020: 1 descendant cleared2021: 2 descendants cleared2024: 1 descendant cleared2026: 5 descendants cleared2025: 6 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 4 descendants6 generations forward: 4 descendants K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 1 generation backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. This deviceK083338 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2009
  3. Descendant · cites it directly · 15 of its ownK112206 Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012
  4. Descendant · 2 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
  5. Descendant · 3 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
  6. Descendant · 3 generations on · 6 of its ownK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
  7. Descendant · 4 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012: 12020: 12021: 22024: 12025: 62026: 5
2012high 6 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 16 · See all
  • K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012 · cites it directly15descendants
  • K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 2 generations on14descendants
  • K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 3 generations on7descendants
  • K212139Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021 · 3 generations on6descendants
  • K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
0 (this device)K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.2009—
+1K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.2012—
+2K202064Admiral ACP SystemSeaSpine Orthopedics Corporation2020—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation2021—
+3K212139Admiral ACP SystemSeaSpine Orthopedics Corporation2021—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec…Alphatec Spine, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
200020
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202010
202120
202410
202560
202650
FIG. 1 — Lineage of K083338, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*K032368Sonoma Anterior Cervical Plate System
Summary page 1
…le predicate device(s): * SeaSpine Sonoma MT Anterior Cervical Plate System (510(k) number K032368) Cardiff PremarketNotification M T * Blackstone TM Anterior Cer…
Seaspine2003—
*K974885Blackstone Medical Inc. Anterior Cervical Plate System
Summary page 2
…arketNotification M T * Blackstone TM Anterior Cervical Plate system (510(k) number K974885) * Medtronic Sofamor Danek Zephir system (510 (k) number…
Blackstone Medical, Inc.1998—
*K994239Zephir Anterior Cervical Plate System
Summary page 2
…T M K994239) * Synthes CSLP System (510(k) numbers K926453, K945700 and…
Medtronic Sofamor Danek, Inc.2000—
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 2
…M K994239) * Synthes CSLP System (510(k) numbers K926453, K945700 and K000536) Performance Data: Mechanical testing results indicated that…
Synthes (Usa)1993—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 2
…M K994239) * Synthes CSLP System (510(k) numbers K926453, K945700 and K000536) Performance Data: Mechanical testing results indicated that Cardiff'…
Synthes (Usa)1995—
*K000536Synthes Anterior CSLP System
Summary page 2
…K994239) * Synthes CSLP System (510(k) numbers K926453, K945700 and K000536) Performance Data: Mechanical testing results indicated that Cardiff' possessed…
Synthes Spine20001

Also cleared against K032368: 2 other devices →

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.201215

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?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K112206 (Seaspine, Inc., 2012) has gone furthest, with 15 descendants of its own.
  • 2 other devices also cite its predicate K032368.

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. 2009, 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?

This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:

* degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

* trauma (including fracture or dislocation),

* spinal stenosis,

* cervical myelopathy,

* deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

* tumor,

* pseudoarthrosis, and/or

* failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K032368

2 other devices cite the same predicate.

  • K170342Ocata Anterior Cervical SystemKalitec Direct, LLC · 2017
  • K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc. · 2012

More from Seaspine, Inc.

27 FDA decisions under this applicant name. See the company

  • K231654NorthStar OCT SystemSeaspine, Inc. · 2023
  • K150469Integra Laminoplasty SystemSeaspine, Inc. · 2015
  • K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu…Seaspine, Inc. · 2014
  • K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc. · 2014
  • K132859Integra Facet Fixation SystemSeaspine, Inc. · 2013

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/K083338 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083338: Cardiff Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083338

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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