510(k) · Cleared
ClearedC-Jaws Cervical Compressive Mini Frame
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea Technologies · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 16, 2007 as substantially equivalent to K021039 (Depuyacromed, 2002) and 1 other predicate after a 169-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 16, 2007
- Review
- 169 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010911 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 1 generation backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- This deviceK062181 C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
- Descendant · cites it directly · 1 of its ownK061385 Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK073500 Active Anterior Cervical Plate SystemSanacor · 2008
- Descendant · cites it directly · 0 of its ownK072040 C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −1 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| 0 (this device) | K062181 | C-Jaws Cervical Compressive Mini Frame | Medicrea Technologies | 2007 | — |
| +1 | K061385 | Osstaple, Ossplate, Ossforce | Biomedical Enterprises, Inc. | 2007 | — |
| +1 | K073500 | Active Anterior Cervical Plate System | Sanacor | 2008 | — |
| +1 | K072040 | C-Jaws Cervical Compressive Mini Frame | Medicrea Technologies | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K021039 | Bowti Anterior Buttress Staple SystemSummary page 1…KWQ CFR section 888. 3060 Device panel Orthopedic Legally marketed predicate BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (K021039) devices MACROPORE OS SPINAL SYSTEM (KO10911) Submitter MEDICREA TECHNOLOGIES… | 2002 |
| * | K010911 | Macropore OS Spinal SystemSummary page 1…pressive Mini Frame is substantially equivalent to the BOWlTI anterior buttress staple system (Depuy Acromed - K021039) and MacroPore OS Spinal System (MacroPore, Inc. - K010911). Page vi .4¢ Us… | 2001 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061385 (Biomedical Enterprises, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K021039.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
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.
https://510kreport.com/device/K062181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062181: C-Jaws Cervical Compressive Mini Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062181
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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