510(k) · Cleared
ClearedJAWS Nitinol Staple 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 Feb 16, 2023 as substantially equivalent to K170923 (Paragon 28, 2017) after a 139-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 16, 2023
- Review
- 139 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001354 (2001). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001354 Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment…Biomedical Ent., Inc. · 2001
- 1 generation backK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · Recalled
- This deviceK223056 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK230550 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261121 Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for… | Biomedical Ent., Inc. | 2001 | — |
| −1 | K170923 | JAWS (TM) Nitinol Staple System | Paragon 28 | 2017 | 1 |
| 0 (this device) | K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +1 | K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K170923 | JAWS (TM) Nitinol Staple SystemSummary page 4…te Prepared: January 20, 2023 Device Trade Name: JAWS Nitinol Staple System Device Class: Class II Predicate Device: JAWS Nitinol Staple System (K170923) Device Description: The JAWS Nitinol Staple System includes three styles of bone staples having various siz… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230550 | JAWS Nitinol Staple System | 2023 | 1 |
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 16.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K230550 (Paragon 28, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223056: JAWS Nitinol Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223056
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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