510(k) · Cleared
ClearedRockwood Clavicle Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDW Pin, Fixation, Threaded
Cleared on Feb 17, 2011 as substantially equivalent to K991649 (Depuy, Inc., 1999) after a 134-day review. Its family tree reaches back 2 generations to 1990. 7 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 134 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903258 (1990). 4 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
- 1 generation backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- This deviceK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK143204 AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
- Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
- Descendant · cites it directly · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143204AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015 · cites it directly2descendants
- K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017 · 2 generations on1descendant
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
- K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 2 generations on0descendants
- K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903258 | Hagie Pin | Onyx Medical Corp. | 1990 | — |
| −1 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| 0 (this device) | K103001 | Rockwood Clavicle Pins | DePuy Orthopaedics, Inc. | 2011 | — |
| +1 | K143204 | AOS Clavicle Intramedullary Device | Advanced Orthopaedic Solutions, Inc. | 2015 | — |
| +2 | K163488 | Flex-Thread Clavicle Pin System | Intrafuse, LLC | 2017 | — |
| +1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| +2 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
| +1 | K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 |
|---|---|---|---|
| * | K991649 | Depuy Rockwood Clavicle PinSummary page 1…Fastener Name of The device is substantially equivalent to the currently marketed DePuy Predicate Rockwood Clavicle Pin System, K991649. Devices Classification Class 11,21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation… | 1999 |
What descends from it? (7)
4 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 21 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143204 (Advanced Orthopaedic Solutions, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K991649.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103001: Rockwood Clavicle Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103001
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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