510(k) · Cleared
ClearedMegalodon Dynamic Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · JDR Staple, Fixation, Bone
Cleared on Aug 6, 2026 as substantially equivalent to K230550 (Paragon 28, Inc., 2023) after a 125-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 6, 2026
- Review
- 125 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001354 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK001354 Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment…Biomedical Ent., Inc. · 2001
- 3 generations backK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · Recalled
- 2 generations backK223056 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- 1 generation backK230550 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- This deviceK261121 Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for… | Biomedical Ent., Inc. | 2001 | — |
| −3 | K170923 | JAWS (TM) Nitinol Staple System | Paragon 28 | 2017 | 1 |
| −2 | K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| −1 | K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| 0 (this device) | K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230550 | JAWS Nitinol Staple SystemSummary page 5…August 05, 2026 Prepared: Device Trade Megalodon Dynamic Compression System Names: Device Class: Class II Primary JAWS Great White Staple System (K230550) Predicate: Device The Megalodon Dynamic Compression System consists of Description: straight 4-leg implants with… | 2023 |
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 25 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Megalodon Dynamic Compression System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of bones and joint of the foot including fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261121: Megalodon Dynamic Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261121
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026