510(k) · Cleared
ClearedBlue Shark
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridan Medical · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 2, 2007 as substantially equivalent to K032427 (Meridan Medical, 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Apr 2, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K803166 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK803166 Double Ball JointHowmedica Corp. · 1981
- 2 generations backK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- 1 generation backK032427 Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003
- This deviceK070016 Blue SharkMeridan Medical · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| −2 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| −1 | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | — |
| 0 (this device) | K070016 | Blue Shark | Meridan Medical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 2001 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K032427 | Fep Fixation System and Stylo Wrist Fixation SystemSummary page 1…he legally marketed device to which we are claiming equivalence 11807.92(a)(3)]: K#_ Device Name Apollicant K032427 FEP Meridian Medical K011697 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P. Regulat… | 2003 |
| * | K011697 | Ebi Xfix Access Pelvic FixatorSummary page 1….92(a)(3)]: K#_ Device Name Apollicant K032427 FEP Meridian Medical K011697 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P. Regulatory Specialists, Inc.… | 2001 |
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 26 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K032427.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type 13 and Type C fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070016: Blue Shark.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070016
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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