510(k) · Cleared
Recalled · 2008Stryker Wedge Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 18, 1998 as substantially equivalent to K960516 (Arthrex, Inc., 1996) after a 66-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 18, 1998
- Review
- 66 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960516 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K041310Stryker Wedge Suture Anchor SystemStryker Endoscopy · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960516 | Fastak Suture Anchor | Arthrex, Inc. | 1996 | — |
| 0 (this device) | K983557 | Stryker Wedge Suture Anchor | Stryker Endoscopy | 1998 | — |
| +1 | K041310 | Stryker Wedge Suture Anchor System | Stryker Endoscopy | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K960516 | Fastak Suture AnchorSummary page 2…quivalent to other suture anchor devices. The Stryker Wedge Suture Anchor System is substantially equivalent to the Arthrex FASTak™ Suture Anchor, marketed under 510(k) K960516, in the following fields: @ ¢ ¢ o 6 o & COMPANY Intended use Material Geometry Thread design Head design Eyelet design O… | 1996 |
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 |
|---|---|---|---|
| K041310 | Stryker Wedge Suture Anchor System | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2008 | Not classified | Z-1538-2008 | Packaging | Product package may crack and cause loss of sterility. |
| Feb 7, 2008 | Not classified | Z-1537-2008 | Packaging | Product package may crack and cause loss of sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended…
Read the full statement (160 words)
The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The suture anchor engages in bone so as to provide a stable bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedure as well, and is intended for single-use only. This device is intended for use only for the fixation of non-absorbable synthetic sutures.
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/K983557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983557: Stryker Wedge Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983557
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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