510(k) · Cleared
ClearedC-Jaws Cervical Compressive Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · PHQ Anterior Staple As Supplemental Fixation For Fusion
Cleared on Jul 24, 2014 as substantially equivalent to K042544 (Depuy Spine, Inc., 2004) and 1 other predicate after a 213-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Jul 24, 2014
- Review
- 213 days
- Class
- Class II
- Product code
- PHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914362 (1992). 3 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK914362 Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc. · 1992
- 1 generation backK042544 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- This deviceK133906 C-Jaws Cervical Compressive StapleMedicrea International · 2014
- Descendant · cites it directly · 0 of its ownK200301 UNiTi ACDF Implant SystemPressio, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K200301UNiTi ACDF Implant SystemPressio, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914362 | Top Cervical Spine Plates & Titanium Bone Screws | Acorn Group, Inc. | 1992 | — |
| −1 | K042544 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K133906 | C-Jaws Cervical Compressive Staple | Medicrea International | 2014 | — |
| +1 | K200301 | UNiTi ACDF Implant System | Pressio, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 PHQ? 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 PHQ device
- #1 K200301 UNiTi ACDF Implant Systemscore 1.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 1…emental fixation for fusion Product Code and Regulation: PHO, 21 C.F.R. 888.3060 Predicate Devices Depuy Spine Uniplate Anterior Cervical Plate System (K042544) Synthes Orozco Plate (K792352) Intended Use /Indications for Use The C-JAWS cervical compressive staple is inte… | 2004 |
| * | K792352 | Synthes Cervical Vertabrae PlatesSummary page 1…de and Regulation: PHO, 21 C.F.R. 888.3060 Predicate Devices Depuy Spine Uniplate Anterior Cervical Plate System (K042544) Synthes Orozco Plate (K792352) Intended Use /Indications for Use The C-JAWS cervical compressive staple is intended for anterior cervical intervertebr… | 1979 |
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 |
|---|---|---|---|
| K200301 | UNiTi ACDF Implant System | 2021 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200301 (Pressio, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 25 other devices also cite its predicate K042544.
How does its category compare?
All PHQ devicesPHQ Anterior Staple As Supplemental Fixation For Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PHQ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PHQ
Too few PHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PHQ
No recall names PHQ since 2007.
Adverse event reports per year · PHQ
1in 2023
MAUDE reports naming product code PHQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The C-JAWS cervical compressive staple is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7. Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one…
Read the full statement (169 words)
The C-JAWS cervical compressive staple is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myclopathy with herniated disc producing symptomatic nerve root and/or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The C-JAWS cervical compressive staple is limited to one level fusion. A single C-JAWS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133906: C-Jaws Cervical Compressive Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133906
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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