510(k) · Cleared
ClearedDynaClip Bone Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedShape, Inc. · JDR Staple, Fixation, Bone
Cleared on Apr 23, 2020 as substantially equivalent to K150125 (Biomedical Enterprises, Inc., 2015) and 1 other predicate after a 146-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 23, 2020
- Review
- 146 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902307 (1990). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 3 generations backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- 2 generations backK133780 Speed XLBiomedical Ent., Inc. · 2014
- 1 generation backK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
- This deviceK193305 DynaClip Bone StapleMedShape, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK220812 DynaClip® Bone StapleMedShape, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K220812DynaClip® Bone StapleMedShape, Inc. · 2022 · cites it directly2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · cites it directly1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −4 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −3 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| −2 | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| −1 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014 | 3 |
| 0 (this device) | K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020 | — |
| +1 | K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022 | — |
| +1 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +2 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K150125 | Elite Nitinol Fixation SystemSummary page 4…R, 21 CFR 888.3030 Class II ͘ Predicate Device: BioMedical Enterprises (BME), Inc. (now DePuySynthes), Elite™ Implant, K150125 BioMedical Enterprises (BME), Inc. (now DePuySynthes), Speed™, Speed Arc™, Speed Titan™ Implant, K142292… | 2015 |
| * | K142292 | Speed, Speed Shift, Speed Titan, Speed ArcSummary page 4…E), Inc. (now DePuySynthes), Elite™ Implant, K150125 BioMedical Enterprises (BME), Inc. (now DePuySynthes), Speed™, Speed Arc™, Speed Titan™ Implant, K142292 &͘ Reference Predicate Device(s): MedShape, Inc., DynaClip Implant, K181781 '͘ Physical Description:… | 2014 |
| † | K181781 | DynaClipTM Bone Staple | 2018 |
What descends from it? (3)
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 30 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K220812 (MedShape, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K150125.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MedShape DynaClip Bone Staple is intended to be used for the following:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Fixation of proximal tibial metaphysis osteotomy.
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 bone 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/K193305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193305: DynaClip Bone Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193305
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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