510(k) · Cleared
ClearedStryker Interference Screw Cross Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · JDW Pin, Fixation, Threaded
Cleared on Mar 15, 2002 as substantially equivalent to K972233 (Stryker Endoscopy, 1997) after a 64-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 15, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972233 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972233 Stryker Wedge Interference Screw SystemStryker Endoscopy · 1997 · Recalled
- This deviceK020097 Stryker Interference Screw Cross Pin SystemStryker Endoscopy · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972233 | Stryker Wedge Interference Screw System | Stryker Endoscopy | 1997 | 1 |
| 0 (this device) | K020097 | Stryker Interference Screw Cross Pin System | Stryker Endoscopy | 2002 | — |
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 |
|---|---|---|---|
| * | K972233 | Stryker Wedge Interference Screw SystemSummary page 1…Common and Usual Name: Threaded Fixation Pin (87 JDW) Proprietary Name: Stryker Interference Screw Cross Pin System Predicate Device Stryker Wedge Interference Screw (#K972233) currently marketed by Stryker Endoscopy (Santa Clara, CA). Summary This summary of 510(k) safety and effectiveness is being su… | 1997 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K972233.
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 Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranous tendon graft, and the Achilles tendon graft.
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/K020097 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020097: Stryker Interference Screw Cross Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020097
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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