510(k) · Cleared
Recalled · Class II · 2017Stryker Wedge Interference Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HWC Screw, Fixation, Bone
Cleared on Aug 5, 1997 after a 50-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 5, 1997
- Review
- 50 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK972233 Stryker Wedge Interference Screw SystemStryker Endoscopy · 1997
- Descendant · cites it directly · 1 of its ownK993166 Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK033252 Modification to Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2003
- Descendant · cites it directly · 0 of its ownK020097 Stryker Interference Screw Cross Pin SystemStryker Endoscopy · 2002
- Descendant · cites it directly · 0 of its ownK012270 Stryker Cross-Pinned Interference Screw SystemStryker Endoscopy · 2001
Most influential descendants
Showing 4 of 4 · See all- K993166Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2000 · cites it directly1descendant
- K033252Modification to Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2003 · 2 generations on0descendants
- K020097Stryker Interference Screw Cross Pin SystemStryker Endoscopy · 2002 · cites it directly0descendants
- K012270Stryker Cross-Pinned Interference Screw SystemStryker Endoscopy · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972233 | Stryker Wedge Interference Screw System | Stryker Endoscopy | 1997 | — |
| +1 | K993166 | Stryker Bioabsorbable Interference Screw System | Stryker Endoscopy | 2000 | 1 |
| +2 | K033252 | Modification to Stryker Bioabsorbable Interference Screw System | Stryker Endoscopy | 2003 | — |
| +1 | K020097 | Stryker Interference Screw Cross Pin System | Stryker Endoscopy | 2002 | — |
| +1 | K012270 | Stryker Cross-Pinned Interference Screw System | Stryker Endoscopy | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2017 | Class II | Z-0837-2018 | Under Investigation by firm | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993166 (Stryker Endoscopy, 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Stryker Wedge Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the femoral and tibial bony attachments of the patelia bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon graits, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts.
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/K972233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972233: Stryker Wedge Interference 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/K972233
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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