510(k) · Cleared
Recalled · 2004Stryker Bioabsorbable 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 4, 2000 as substantially equivalent to K973758 (Linvatec Corp., 1998) and 1 other predicate after a 317-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 4, 2000
- Review
- 317 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972233 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972233 Stryker Wedge Interference Screw SystemStryker Endoscopy · 1997 · Recalled
- This deviceK993166 Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2000
- Descendant · cites it directly · 0 of its ownK033252 Modification to Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2003
Most influential descendants
Showing 1 of 1 · See all- K033252Modification to Stryker Bioabsorbable Interference Screw SystemStryker Endoscopy · 2003 · cites it directly0descendants
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) | K993166 | Stryker Bioabsorbable Interference Screw System | Stryker Endoscopy | 2000 | — |
| +1 | K033252 | Modification to Stryker Bioabsorbable Interference Screw System | Stryker Endoscopy | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K973758 | Bioscrew Absorbable Interference SrewSummary page 1…ction and its overall design are equivalent to currently marketed products, The Stryker Bioabsorbable Screw is substantially equivalent to the Linvatec BioScrew (510(k) K973758 ) in the following fields: Intended use Material Thread design Head design Shelf life Summary of Safety and Effectiveness page… | 1998 |
| * | K972233 | Stryker Wedge Interference Screw SystemSummary page 2…mary of Safety and Effectiveness page 1 of 3 The Stryker Bioabsorbable Screw is substantially equivalent to the Stryker Wedge Interference Screw (510(k) K972233 ) in the following fields: Geometry Bead design Intended use Thread design €< 9 Tl Summary of Safety and Effectiveness page… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033252 | Modification to Stryker Bioabsorbable Interference Screw System | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2004 | Not classified | Z-0401-05 | Other | The label on the outside of the shipping box has an incorrect description of the screw diameter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
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/K993166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993166: Stryker Bioabsorbable 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/K993166
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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