510(k) Report

510(k) · Cleared

Recalled · 2004

Trinica Select Anterior Cervical Plate System

K022344510(k) SpecialCleared Sep 24, 200267-day reviewClass II21 CFR 888.3060Recalls 1

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

Centerpulse Spine-Tech, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 24, 2002 as substantially equivalent to K012305 (Sulzer Spine-Tech, 2001) and 4 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1993. 43 later devices descend from it. It has been recalled once.

Decided
Sep 24, 2002
Review
67 days
Class
Class II
Product code
KWQ
Recalls
1
Predicates
5

Its longest line of descent runs back 2 generations to K926453 (1993). 6 ancestors in all. 43 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor2011: 1 descendant cleared2021: 4 descendants cleared2003: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2004: 3 descendants cleared2008: 2 descendants cleared2017: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2015: 2 descendants cleared2020: 2 descendants cleared2016: 2 descendants cleared2006: 1 descendant cleared2019: 3 descendants cleared2018: 1 descendant cleared2023: 8 descendants cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 2 descendants cleared2022: 2 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 12 descendants3 generations forward: 12 descendants4 generations forward: 6 descendants5 generations forward: 5 descendants6 generations forward: 2 descendants K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 1 generation backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. This deviceK022344 Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc. · 2002
  4. Descendant · cites it directly · 22 of its ownK132012 Trinica (R) Anterior Cervical Plate System, Trinica (R) Select…Zimmer Spine, Inc. · 2013
  5. Descendant · cites it directly · 18 of its ownK111796 Invizia Anterior Cervical Plate SystemZimmer Spine, Inc. · 2011
  6. Descendant · 2 generations on · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
  7. Descendant · 3 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
  8. Descendant · cites it directly · 12 of its ownK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2003: 12004: 32005: 12006: 12008: 22009: 12011: 12012: 12013: 22015: 22016: 22017: 12018: 12019: 32020: 22021: 42022: 22023: 82024: 22025: 12026: 2
2003high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 43 · See all
  • K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc. · 2013 · cites it directly22descendants
  • K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc. · 2011 · cites it directly18descendants
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · 2 generations on16descendants
  • K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 3 generations on13descendants
  • K040003Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004 · cites it directly12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−1K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
0 (this device)K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.2002—
+1K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior…Zimmer Spine, Inc.2013—
+1K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.2011—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical…Zimmer Spine, Inc.2015—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2020—
+1K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
200510
200610
200820
200910
201110
201210
201320
201520
201620
201710
201810
201930
202020
202140
202220
202380
202420
202510
202620
FIG. 1 — Lineage of K022344, 1993–2026Source: 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? (5)

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
*K012305Modification to: Trinica Anterior Cervical Plate SystemSulzer Spine-Tech2001—
*K974435Michelson Anterior Cervical Plate System
Summary page 1
…Plating System KO12305, concurrence date August 22, 2001 Michelson Anterior Cervical Plate K974435, concurrence date February 19, 1998 Synthes Anterior Cervical Spine Locking Plate…
Wrightmedicaltechnologyinc1998—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 1
…K974435, concurrence date February 19, 1998 Synthes Anterior Cervical Spine Locking Plate K945700, concurrence date July 20, 1995 Synthes Spine Small Stature Anterior Cervical…
Synthes (Usa)1995—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…date July 20, 1995 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate Systemru K971883, concurrence date October 16, 1997 Medt ronic Sofamor- Danek Ze phir Anterior…
Synthes (Usa)19971
*K994239Zephir Anterior Cervical Plate System
Summary page 1
…nce date October 16, 1997 Medt ronic Sofamor- Danek Ze phir Anterior Cervical Plate System K994239, concurrence date June 19,2000 T…
Medtronic Sofamor Danek, Inc.2000—

Also cleared against K012305: 3 other devices →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc.201322
K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118
K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412
K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121
K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P.20031
K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine20210

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 21, 2004Not classifiedZ-1014-04OtherThe recalled bone taps could break inside the vertebral body during the tapping process.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K132012 (Zimmer Spine, Inc., 2013) has gone furthest, with 22 descendants of its own.
  • 3 other devices also cite its predicate K012305.

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.

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 Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-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 degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including…

Read the full statement (103 words)

The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-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 degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K012305

3 other devices cite the same predicate.

  • K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
  • K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate SystemZimmer Spine, Inc. · 2013
  • K120515Tempus Cervical Plate SystemNeurostructures, LLC · 2012

More from Centerpulse Spine-Tech, Inc.

4 FDA decisions under this applicant name. See the company

  • K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
  • K031511Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 20044 recalls
  • K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc. · 2002

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/K022344 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022344: Trinica Select 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/K022344

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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