510(k) · Cleared
ClearedSpeed Triad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Ent., Inc. · JDR Staple, Fixation, Bone
Cleared on Apr 7, 2014 as substantially equivalent to K124022 (Biomedical Enterprises, Inc., 2013) and 1 other predicate after a 110-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 7, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960385 (1996). 9 ancestors in all, the oldest K902307 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- This deviceK133844 Speed TriadBiomedical Ent., Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| 0 (this device) | K133844 | Speed Triad | Biomedical Ent., Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K124022 | Speed ShiftSummary page 1…fixation and joint arthrodesis of the hand and foot. Substantial Equivalence: The Speed Triad is substantially equivalent to the predicate BME Speed ShiftTM cleared in K124022, predicate OSSplateTM cleared in K093714, labeled as the Memograph®) Staple, and predicate K070598 (SmartToe). The K993714 predic… | 2013 |
| Kept off the family tree | K093714 | FDA’s K093714 is Sonoace X8 Diagnostic Ultrasound System Our reading of the summary gave K093714, FDA’s number for Sonoace X8 Diagnostic Ultrasound System (Medison Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OSSplate”. Kept off the family tree. Summary page 1…d and foot. Substantial Equivalence: The Speed Triad is substantially equivalent to the predicate BME Speed ShiftTM cleared in K124022, predicate OSSplateTM cleared in K093714, labeled as the Memograph®) Staple, and predicate K070598 (SmartToe). The K993714 predicate also includes an intended use of fixa… | 2009 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 1…substantially equivalent to the predicate BME Speed ShiftTM cleared in K124022, predicate OSSplateTM cleared in K093714, labeled as the Memograph®) Staple, and predicate K070598 (SmartToe). The K993714 predicate also includes an intended use of fixation of proximal tibial metaphysis osteotomy and fixation… | 2007 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 4 other devices also cite its predicate K124022.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Speed TriadTM is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the
hand and foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133844: Speed Triad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133844
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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