510(k) Report

510(k) · Cleared

Cleared

C-Jaws Cervical Compressive Mini Frame

K072040510(k) SpecialCleared Aug 3, 20079-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

Medicrea Technologies · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 3, 2007 as substantially equivalent to K062181 (Medicrea Technologies, 2007) after a 9-day review. Its family tree reaches back 3 generations to 2001.

Decided
Aug 3, 2007
Review
9 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K010911 (2001). No later device cites it as a predicate yet.

  1. Root · 3 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
  2. 2 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
  3. 1 generation backK062181 C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
  4. This deviceK072040 C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010911Macropore OS Spinal SystemMacropore Biosurgery, Inc.2001—
−2K021039Bowti Anterior Buttress Staple SystemDepuyacromed2002—
−1K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies2007—
0 (this device)K072040C-Jaws Cervical Compressive Mini FrameMedicrea Technologies2007—
FIG. 1 — Lineage of K072040, 2001–2007Source: 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
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What was it cleared against? (1)

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
*K062181C-Jaws Cervical Compressive Mini Frame
Summary page 1
…roduct Code KWQ CFR section 888.3060 Device panel Orthopedic Legally marketed C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181) predicate devices Submitter MEDICREATM TECHNOLOGIES ZI Chef de Bate…
Medicrea Technologies2007—

Also cleared against K062181: 2 other devices →

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 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K062181.

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 C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended

for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue

such as allograft or auto grafts. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072040: C-Jaws Cervical Compressive Mini Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072040

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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