510(k) Report

510(k) · Cleared

Cleared

Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion

K953720510(k) TraditionalCleared Nov 2, 199585-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

Aesculap, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 2, 1995 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Nov 2, 1995
Review
85 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

16 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2012: 2 descendants cleared1998: 1 descendant cleared2014: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953720 Aesculap Caspar Plate & Screw System for Anterior Cervical FusionAesculap, Inc. · 1995
  2. Descendant · cites it directly · 10 of its ownK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
  5. Descendant · cites it directly · 3 of its ownK122216 Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012
  6. Descendant · 4 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1998: 12010: 12012: 22014: 22018: 12020: 12021: 12022: 12023: 12024: 12025: 22026: 2
1998high 2 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 16 · See all
  • K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · cites it directly10descendants
  • K141993Nakoma AcpAlliance Partners, LLC · 2014 · 2 generations on8descendants
  • K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
  • K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012 · cites it directly3descendants
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953720Aesculap Caspar Plate & Screw System for Anterior Cervical FusionAesculap, Inc.1995—
+1K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC20101
+2K141993Nakoma AcpAlliance Partners, LLC20141
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2023—
+1K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC2012—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201010
201220
201420
201810
202010
202110
202210
202310
202410
202520
202620
FIG. 1 — Lineage of K953720, 1995–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC201010
K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123
K981008Simal Cervical Stabilization SystemTop Surgical Products GmbH19980

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?

  • Of its descendants, K100243 (Aesculap Implant Systems, LLC, 2010) has gone furthest, with 10 descendants of its own.

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—
Cite this page

510(k) Report. “K953720: Aesculap Caspar Plate & Screw System for Anterior Cervical Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953720

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026