510(k) · Cleared
ClearedDynaBridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics, LLC · JDR Staple, Fixation, Bone
Cleared on Oct 15, 2018 as substantially equivalent to K142292 (Biomedical Enterprises, Inc., 2014) and 2 other predicates after a 98-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Oct 15, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K902307 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 5 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 4 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 3 generations backK123926 Metasurg Nitinol Staple ImplantMetasurg · 2013
- 2 generations backK162354 Sniper Staple SystemTrilliant Surgical, Ltd. · 2017
- 1 generation backK172405 Sniper Staple System, Non-SterileTrilliant Surgical · 2017
- This deviceK181815 DynaBridgeFusion Orthopedics, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −5 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −4 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −3 | K123926 | Metasurg Nitinol Staple Implant | Metasurg | 2013 | — |
| −2 | K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017 | — |
| −1 | K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical | 2017 | — |
| 0 (this device) | K181815 | DynaBridge | Fusion Orthopedics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K142292 | Speed, Speed Shift, Speed Titan, Speed ArcSummary page 4…JDR CFR Section: 21CFR section 888.3030 Device Panel: Orthopedic Primary Predicate Speed Staple, BioMedical Enterprises, Inc. (K142292) Devices: Secondary Predicate Sniper Staple System, Trilliant Surgical (K1623545/ K172405) Devices:… | 2014 |
| * | K162354 | Sniper Staple SystemSummary page 4…ry Predicate Speed Staple, BioMedical Enterprises, Inc. (K142292) Devices: Secondary Predicate Sniper Staple System, Trilliant Surgical (K1623545/ K172405) Devices: The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy… | 2017 |
| * | K172405 | Sniper Staple System, Non-SterileSummary page 4…te Speed Staple, BioMedical Enterprises, Inc. (K142292) Devices: Secondary Predicate Sniper Staple System, Trilliant Surgical (K1623545/ K172405) Devices: The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy… | 2017 |
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 28 years and passes through 7 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 8 other devices also cite its predicate K142292.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DynaBridge is indicated for:
* Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
* Fixation of proximal tibial metaphysis osteotomy.
» Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
* Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
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/K181815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181815: DynaBridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181815
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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