510(k) · Cleared
Cleared3.9MM Reelx STT Suture Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 18, 2012 as substantially equivalent to K090530 (Ross Creek Medical, Inc., 2009) and 2 other predicates after a 121-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Jul 18, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K012125 (2001). 26 ancestors in all, the oldest K954808 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
- 4 generations backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
- 3 generations backK060914 Trident AnchorJohnson & Johnson Company · 2006
- 2 generations backK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
- 1 generation backK090530 Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc. · 2009
- This deviceK120824 3.9MM Reelx STT Suture Anchor SystemStryker Corp. · 2012
- Descendant · cites it directly · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K180759SECULOK™ Suture AnchorU&I Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012125 | Opus Magnum Anchor & Inserter | Opus Medical, Inc. | 2001 | — |
| −4 | K042914 | Opus Magnum Knotless Anchor with Inserter Handle | Opus Medical, Inc. | 2004 | — |
| −3 | K060914 | Trident Anchor | Johnson & Johnson Company | 2006 | — |
| −2 | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond… | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −1 | K090530 | Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01 | Ross Creek Medical, Inc. | 2009 | — |
| 0 (this device) | K120824 | 3.9MM Reelx STT Suture Anchor System | Stryker Corp. | 2012 | — |
| +1 | K180759 | SECULOK™ Suture Anchor | U&I Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K090530 | Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Summary page 1…: (303) 336-7285; Fax (303) 370-5775 Email: kelly.kucharczyk~stryker.com Legally Marketed Devices to Which K090530 - Spin-Loc Suture Anchor System (legally Substantial Equivalence Is Claimed: marketed as Stryker ReelX STT Suture A… | 2009 |
| * | K051219 | PushlockSummary page 1…ure Anchor System (legally Substantial Equivalence Is Claimed: marketed as Stryker ReelX STT Suture Anchor) K05 12 19 - Arthrex PushLock K970896 - DePuy Mucek Panalok Anchor Date Prepared:… | 2005 |
| * | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemSummary page 1…marketed as Stryker ReelX STT Suture Anchor) K05 12 19 - Arthrex PushLock K970896 - DePuy Mucek Panalok Anchor Date Prepared: July IL 2012 Purpose Stryker currently offers a 5… | 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 |
|---|---|---|---|
| K180759 | SECULOK™ Suture Anchor | 2018 | 0 |
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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K180759 (U&I Corporation, 2018) has gone furthest, with 0 descendants of its own.
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. 2012, this device’s year, is highlighted.
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 ReelX SIT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures: Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift/Capsulolabral Reconstruction Knee: Medial Collateral Ligament Repair Lateral Collateral…
Read the full statement (109 words)
The ReelX SIT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:
Shoulder: Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capsular Shift/Capsulolabral Reconstruction
Knee: Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Illiotibial Band Tenodesis
Foot and Ankde: Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair
Elbow: Biceps Tendon Reattachiment
The ReeiX STT Suture Anchor System is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120824: 3.9MM Reelx STT Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120824
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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