510(k) · Cleared
ClearedElite Nitinol Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Enterprises, Inc. · JDR Staple, Fixation, Bone
Cleared on May 11, 2015 as substantially equivalent to K133780 (Biomedical Ent., Inc., 2014) after a 111-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- May 11, 2015
- Review
- 111 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902307 (1990). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- 1 generation backK133780 Speed XLBiomedical Ent., Inc. · 2014
- This deviceK150125 Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK220812 DynaClip® Bone StapleMedShape, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK221947 Tyber Medical Staple Fixation System (various)Tyber Medical, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K193305DynaClip Bone StapleMedShape, Inc. · 2020 · cites it directly3descendants
- K220812DynaClip® Bone StapleMedShape, Inc. · 2022 · 2 generations on2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 2 generations on1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · 3 generations on0descendants
- K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| −1 | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| 0 (this device) | K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | 2015 | — |
| +1 | K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020 | — |
| +2 | K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022 | — |
| +2 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +3 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
| +1 | K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K133780 | Speed XLSummary page 4…0 – Class II) Device Product Code, Device Panel: JDR – Orthopedic 3. Primary Predicate: Speed Titan™ (formerly cleared as Speed XL K133780) Reference Devices: OSSplate™ (formerly cleared as Memograph Staple… | 2014 |
| † | K993714 | Memograph Staple, Warm System | 2000 |
| † | K133844 | Speed Triad | 2014 |
What descends from it? (5)
2 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 25 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K193305 (MedShape, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133780.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Fixation of small fragments of bone (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 bone such as the pelvis, scapula and sternum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150125: Elite Nitinol Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150125
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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