510(k) · Cleared
Recalled · Class II · 2017TRYPTIK2C-plate Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 28, 2016 as substantially equivalent to K072650 (Innovative Spinal Technologies, Inc., 2007) and 4 other predicates after a 161-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Mar 28, 2016
- Review
- 161 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 7
- Predicates
- 5
Its longest line of descent runs back 3 generations to K922087 (1992). 12 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 2 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 1 generation backK043082 The Tosca Anterior Cervical Plate SystemSignus Medizintechnik GmbH · 2004
- This deviceK153042 TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 2016
- Descendant · cites it directly · 0 of its ownK171797 TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart · 2018
Most influential descendants
Showing 1 of 1 · See all- K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −2 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −1 | K043082 | The Tosca Anterior Cervical Plate System | Signus Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | Spineart | 2016 | — |
| +1 | K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | Spineart | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072650 | Ist Anterior Cervical Plate SystemSummary page 4…is Device panel ORTHOPEDIC Legally marketed predicate devices Primary predicate: IST Anterior Cervical Plate System manufactured by Innovative Spinal Technologies Inc (K072650) Other predicates: Synthes Cervical Vertabrae Plates manufactured by Depuy Synthes (K792352); Synthes Anterior Cervical Vertebra… | 2007 |
| * | K792352 | Synthes Cervical Vertabrae PlatesSummary page 4…or Cervical Plate System manufactured by Innovative Spinal Technologies Inc (K072650) Other predicates: Synthes Cervical Vertabrae Plates manufactured by Depuy Synthes (K792352); Synthes Anterior Cervical Vertebrae Plate manufactured by Synthes USA (K926453); Tosca Anterior Cervical Plate System manufactu… | 1979 |
| * | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSummary page 4…650) Other predicates: Synthes Cervical Vertabrae Plates manufactured by Depuy Synthes (K792352); Synthes Anterior Cervical Vertebrae Plate manufactured by Synthes USA (K926453); Tosca Anterior Cervical Plate System manufactured by Signus Medizintechnik GMBH (K043082);Spider Cervical Plating (SCP) System… | 1993 |
| * | K043082 | The Tosca Anterior Cervical Plate SystemSummary page 4…92352); Synthes Anterior Cervical Vertebrae Plate manufactured by Synthes USA (K926453); Tosca Anterior Cervical Plate System manufactured by Signus Medizintechnik GMBH (K043082);Spider Cervical Plating (SCP) System manufactured by X-SPINE SYSTEMS, INC. (K052292) Indications for use TRYPTIKZC-pm: Anterio… | 2004 |
| * | K052292 | Spider Cervical Plating (SCP) SystemSummary page 4…3); Tosca Anterior Cervical Plate System manufactured by Signus Medizintechnik GMBH (K043082);Spider Cervical Plating (SCP) System manufactured by X-SPINE SYSTEMS, INC. (K052292) Indications for use TRYPTIKZC-pm: Anterior Cervical Plate System is intended to be used for temporary stabilization of the cer… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2017 | Class II | Z-0336-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0337-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0338-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0339-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0340-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0341-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
| Nov 27, 2017 | Class II | Z-0342-2018 | Error in labeling | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K171797 (Spineart, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072650.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
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.
https://510kreport.com/device/K153042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153042: TRYPTIK2C-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/K153042
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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