510(k) Report

510(k) · Cleared

Cleared

Ist Anterior Cervical Plate System

K072650510(k) TraditionalCleared Nov 28, 200770-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

Innovative Spinal Technologies, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 28, 2007 as substantially equivalent to K041469 (X-Spine Systems, 2004) and 3 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1993. 8 later devices descend from it.

Decided
Nov 28, 2007
Review
70 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K926453 (1993). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1995: 1 other ancestor2016: 2 descendants cleared2019: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930
  1. Root · 1 generation backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. This deviceK072650 Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc. · 2007
  3. Descendant · cites it directly · 3 of its ownK160604 Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2016
  4. Descendant · cites it directly · 1 of its ownK182489 4CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
  5. Descendant · 2 generations on · 1 of its ownK181543 Cure™ OPEL-C Plate SystemMeditech Spine, LLC · 2018
  6. Descendant · cites it directly · 1 of its ownK153042 TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 2016 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK223321 Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016: 22018: 22019: 12020: 12021: 12023: 1
2016high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2016 · cites it directly3descendants
  • K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019 · cites it directly1descendant
  • K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC · 2018 · 2 generations on1descendant
  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 2016 · cites it directly1descendant
  • K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023 · 2 generations on0descendants
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)K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc.2007—
+1K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC2016—
+1K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.2019—
+2K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC2018—
+1K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart20167
+2K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201820
201910
202010
202110
202310
FIG. 1 — Lineage of K072650, 1993–2023Source: 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
*K041469Anterior Compact System
Summary page 1
…s, or scoliosis) * Pseudoarthrosis * Failed previous fusions PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866) PERFORMANCE DATA: The mechanical test results based on AST…
X-Spine Systems2004—
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 1
…hrosis * Failed previous fusions PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866) PERFORMANCE DATA: The mechanical test results based on ASTM F1717 demonstrate that the IST A…
Synthes (Usa)1993—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 1
…* Failed previous fusions PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866) PERFORMANCE DATA: The mechanical test results based on ASTM F1717 demonstrate that the IST ACP System…
Synthes (Usa)1995—
*K030866Synthes Anterior CSLP System
Summary page 1
…previous fusions PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866) PERFORMANCE DATA: The mechanical test results based on ASTM F1717 demonstrate that the IST ACP System can be expe…
Synthes (Usa)2003—

Also cleared against K041469: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC20163
K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191
K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart20161

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K160604 (Meditech Spine, LLC, 2016) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K041469.

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. 2007, 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 IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

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

* Spondylolisthesis

* Trauma (i.e., fractures or dislocations)

* Tumors

* Deformity (defined as kyphosis, lordosis, or scoliosis)

* Pseudoarthrosis

* Failed previous fusions

Indications for use as stated in the FDA summary.

Also cleared against K041469

2 other devices cite the same predicate.

  • K100265Diamond Anterior Cervical Plate SystemAmendia, Inc. · 2010
  • K091134Custom Spine Regent Anterior Cervical PlateCustom Spine, Inc. · 2009

More from Innovative Spinal Technologies, Inc.

4 FDA decisions under this applicant name. See the company

  • K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  • K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  • K053276Ist Pedicle Screw SystemInnovative Spinal Technologies, Inc. · 2005

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/K072650 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072650: Ist Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072650

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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