510(k) · Cleared
ClearedOsstaple Chill
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 Sep 3, 2010 after a 38-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Sep 3, 2010
- Review
- 38 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK102107 Osstaple ChillBiomedical Ent., Inc. · 2010
- Descendant · cites it directly · 20 of its ownK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
- Descendant · 2 generations on · 15 of its ownK133780 Speed XLBiomedical Ent., Inc. · 2014
- Descendant · 2 generations on · 13 of its ownK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK150125 Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K124022Speed ShiftBiomedical Enterprises, Inc. · 2013 · cites it directly20descendants
- K133780Speed XLBiomedical Ent., Inc. · 2014 · 2 generations on15descendants
- K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · 2 generations on13descendants
- K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015 · 3 generations on5descendants
- K193305DynaClip Bone StapleMedShape, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102107 | Osstaple Chill | Biomedical Ent., Inc. | 2010 | — |
| +1 | K124022 | Speed Shift | Biomedical Enterprises, Inc. | 2013 | — |
| +2 | K133780 | Speed XL | Biomedical Ent., Inc. | 2014 | — |
| +2 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014 | 3 |
| +3 | K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | 2015 | — |
| +3 | K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 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 |
|---|---|---|---|
| * | — | BME OSStaple™ Named without a submission number |
What descends from it? (24)
See all 243 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?
- Of its descendants, K124022 (Biomedical Enterprises, Inc., 2013) has gone furthest, with 20 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 OSStaple™ Chill is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and
Fixation of proximal tibial metaphysis osteotomy.
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/K102107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102107: Osstaple Chill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102107
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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