510(k) Report

510(k) · Cleared

Cleared

Sintea Plustek Anterior Cervical Plate System

K112861510(k) SpecialCleared Feb 24, 2012147-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

Sintea Plustek, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 24, 2012 as substantially equivalent to K041989 (Sintea Biotech, Inc., 2004) and 2 other predicates after a 147-day review. Its family tree reaches back 4 generations to 1995.

Decided
Feb 24, 2012
Review
147 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K953730 (1995). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2000: 2 other ancestorsK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K052552 · Hybrid Anterior Cervical Plate System · Depuy Spine, Inc. · 2005 · recalledK103491 · Skyline Anterior Cervical Plate System · A Johnson & Johnson Company · 20111995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K103491 · Skyline Anterior Cervical Plate System · A Johnson & Johnson Company · 2011K052552 · Hybrid Anterior Cervical Plate System · Depuy Spine, Inc. · 2005 · recalledK013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 19950
  1. Root · 4 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 3 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 2 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
  4. 1 generation backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
  5. This deviceK112861 Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−3K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−2K052552Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc.20057
−1K103491Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company2011—
0 (this device)K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200410
FIG. 1 — Lineage of K112861, 1995–2012Source: 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? (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
*K041989Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X
Summary page 2
…05-673-6226 F. 305-673-33 12 V. Predicate Devices The Sintea Plustek Atnerior Cervical Plate is substantially equivalent to the Sintea Biotech Anterior Cervical Plate (K04 1989), the Synthes CSLP Variable Angle Plate (K000536) and the DePuy Skyline ACP (K103491). VI. Performance Data - Overview The te…
Sintea Biotech, Inc.2004—
*K000536Synthes Anterior CSLP System
Summary page 2
…s The Sintea Plustek Atnerior Cervical Plate is substantially equivalent to the Sintea Biotech Anterior Cervical Plate (K04 1989), the Synthes CSLP Variable Angle Plate (K000536) and the DePuy Skyline ACP (K103491). VI. Performance Data - Overview The testing completed for the device under review was p…
Synthes Spine20001
*K103491Skyline Anterior Cervical Plate System
Summary page 2
…al Plate is substantially equivalent to the Sintea Biotech Anterior Cervical Plate (K04 1989), the Synthes CSLP Variable Angle Plate (K000536) and the DePuy Skyline ACP (K103491). VI. Performance Data - Overview The testing completed for the device under review was performed according to ASTM F 1717-09…
A Johnson & Johnson Company2011—

What descends from it?

No later submission names this one as a predicate yet.

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 5 companies; a new generation was cleared every 5.3 years on median.
  • 2 of the 7 ancestors have a recall of any class.

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. 2012, 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 Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

* Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

* Spondylolisthesis

* Trauma (fracture or dislocation)

* Spinal stenosis

* Deformities or curvatures (scoliosis, kyphosis, lordosis)

* Tumor

* Pseudarthrosis

* Failed previous fusion

Indications for use as stated in the FDA summary.

More from Sintea Plustek, LLC

3 FDA decisions under this applicant name. See the company

  • K140787PLS (Posterior Lumbar System)Sintea Plustek, LLC · 2014
  • K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC · 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/K112861 · printed Nov 5, 2026

Cite this page

510(k) Report. “K112861: Sintea Plustek 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/K112861

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