510(k) · Cleared
ClearedDepuy Cannulated Cross Pin Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JDW Pin, Fixation, Threaded
Cleared on Dec 16, 1996 as substantially equivalent to K954630 (Depuy, Inc., 1995) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 16, 1996
- Review
- 74 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946228 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946228 Cross Pin Screw SystemDepuy, Inc. · 1995
- This deviceK963973 Depuy Cannulated Cross Pin Screw SystemDepuy, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946228 | Cross Pin Screw System | Depuy, Inc. | 1995 | — |
| 0 (this device) | K963973 | Depuy Cannulated Cross Pin Screw System | Depuy, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K954630 | Depuy Titanium Cross Pin Fixation SystemSummary page 1…reconstruction. BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Cannulated Cross Pin Screw System is substantially equivalent to the DePuy Titanium Cross Pin Screw System (K954630), the DePuy Cross Pin System (K946228), and the Arthrex SemiFix ACL Reconstruction System. The substantial equivalency is based o… | 1995 |
| * | K946228 | Cross Pin Screw SystemSummary page 1…EQUIVALENCE: The DePuy Cannulated Cross Pin Screw System is substantially equivalent to the DePuy Titanium Cross Pin Screw System (K954630), the DePuy Cross Pin System (K946228), and the Arthrex SemiFix ACL Reconstruction System. The substantial equivalency is based on similar material, intended uses and… | 1995 |
| * | — | Arthrex SemiFix ACL Reconstruction System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction.
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/K963973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963973: Depuy Cannulated Cross Pin Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963973
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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