510(k) Report

510(k) · Cleared

Cleared

TRYPTIK2 C-Plate Anterior Cervical Plate System

K171797510(k) TraditionalCleared Feb 26, 2018255-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

Spineart · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 26, 2018 as substantially equivalent to K153042 (Spineart, 2016) and 3 other predicates after a 255-day review. Its family tree reaches back 4 generations to 1992.

Decided
Feb 26, 2018
Review
255 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K922087 (1992). 20 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2005: 2 other ancestors2007: 1 other ancestor2004: 3 other ancestors2000: 1 other ancestor1993: 1 other ancestor1979: 1 other ancestor2003: 2 other ancestors1998: 1 other ancestor1995: 2 other ancestors1980: 1 other ancestorK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK043082 · The Tosca Anterior Cervical Plate System · Signus Medizintechnik GmbH · 2004K153042 · TRYPTIK2C-plate Anterior Cervical Plate System · Spineart · 2016 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 6 other ancestors K153042 · TRYPTIK2C-plate Anterior Cervical Plate System · Spineart · 2016 · recalledK043082 · The Tosca Anterior Cervical Plate System · Signus Medizintechnik GmbH · 2004K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920
  1. Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 2 generations backK043082 The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH · 2004
  4. 1 generation backK153042 TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 2016 · Recalled
  5. This deviceK171797 TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−3K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−2K043082The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH2004—
−1K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart20167
0 (this device)K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199310
199520
199810
200010
200320
200430
200520
200710
201010
FIG. 1 — Lineage of K171797, 1992–2018Source: 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? (4)

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
*K153042TRYPTIK2C-plate Anterior Cervical Plate System
Summary page 4
…panel ORTHOPEDIC Primary predicate: Tryptik2c-Plate Anterior Cervical Plate manufactured by Spineart K153042 Legally marketed Additional predicates: Diamond Anterior Cervical Plate System manufactured by predicate devices…
Spineart20167
*K100265Diamond Anterior Cervical Plate System
Summary page 4
…Spineart K153042 Legally marketed Additional predicates: Diamond Anterior Cervical Plate System manufactured by predicate devices Amendia, Inc (K100265), Spider Cervical Plating (SCP) System manufactured by X- Spine Systems, Inc (K052292) and Vectra Syst…
Amendia, Inc.2010—
*K052292Spider Cervical Plating (SCP) System
Summary page 4
…manufactured by predicate devices Amendia, Inc (K100265), Spider Cervical Plating (SCP) System manufactured by X- Spine Systems, Inc (K052292) and Vectra System manufactured by Synthes Spine CO.LP (K050451) TRYPTIK2C-…
X-Spine Systems, Inc.2005—
*K050451Synthes Vectra System
Summary page 4
…(SCP) System manufactured by X- Spine Systems, Inc (K052292) and Vectra System manufactured by Synthes Spine CO.LP (K050451) TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for…
Synthes Spine Co.Lp20053

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 26 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
  • 4 of the 20 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. 2018, 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?

TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Spineart

44 FDA decisions under this applicant name. See the company

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  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020

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The KWQ category page

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https://510kreport.com/device/K171797 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171797: TRYPTIK2 C-Plate Anterior 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/K171797

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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