510(k) · Cleared
ClearedSpeed XL
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 Mar 19, 2014 as substantially equivalent to K124022 (Biomedical Enterprises, Inc., 2013) after a 97-day review. Its family tree reaches back 3 generations to 1990. 15 later devices descend from it.
- Decided
- Mar 19, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902307 (1990). 5 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 1 generation backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- This deviceK133780 Speed XLBiomedical Ent., Inc. · 2014
- Descendant · cites it directly · 13 of its ownK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
- Descendant · cites it directly · 5 of its ownK150125 Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK220812 DynaClip® Bone StapleMedShape, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · cites it directly13descendants
- K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015 · cites it directly5descendants
- K193305DynaClip Bone StapleMedShape, Inc. · 2020 · 2 generations on3descendants
- K220812DynaClip® Bone StapleMedShape, Inc. · 2022 · 3 generations on2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −2 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −1 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| 0 (this device) | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| +1 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014 | 3 |
| +1 | K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | 2015 | — |
| +2 | K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020 | — |
| +3 | K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022 | — |
| +3 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K124022 | Speed ShiftSummary page 1…eotomy fixation and joint arthrodesis of the hand and foot. Substantial Equivalence: The Speed XLTM is substantially equivalent to the predicate Speed ShiftiM cleared in K 124022. Device Description The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The… | 2013 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142292 (Biomedical Enterprises, Inc., 2014) has gone furthest, with 13 descendants of its own.
- 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 XL™ 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/K133780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133780: Speed XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133780
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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