510(k) · Cleared
ClearedSpin-Loc Suture Anchor System FG-0302-01,FG-0305-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ross Creek Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 20, 2009 as substantially equivalent to K063479 (Arthrex, Inc., 2006) and 2 other predicates after an 82-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- May 20, 2009
- Review
- 82 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K012125 (2001). 24 ancestors in all, the oldest K954808 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK012125 Opus Magnum Anchor & InserterOpus Medical, Inc. · 2001
- 3 generations backK042914 Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
- 2 generations backK060914 Trident AnchorJohnson & Johnson Company · 2006
- 1 generation backK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006
- This deviceK090530 Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK120824 3.9MM Reelx STT Suture Anchor SystemStryker Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012125 | Opus Magnum Anchor & Inserter | Opus Medical, Inc. | 2001 | — |
| −3 | K042914 | Opus Magnum Knotless Anchor with Inserter Handle | Opus Medical, Inc. | 2004 | — |
| −2 | K060914 | Trident Anchor | Johnson & Johnson Company | 2006 | — |
| −1 | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond… | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| 0 (this device) | K090530 | Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01 | Ross Creek Medical, Inc. | 2009 | — |
| +1 | K120824 | 3.9MM Reelx STT Suture Anchor System | Stryker Corp. | 2012 | — |
| +2 | 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 | 2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063479 | Arthrex PushlockSummary page 1…edicate Devices Manufacturer Device Name 510(k) Number Arthrex PushLock K063479 Mitek Versalok K063478 Teleflex Medical Force Fiber… | 2006 |
| * | K063478 | Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Summary page 1…510(k) Number Arthrex PushLock K063479 Mitek Versalok K063478 Teleflex Medical Force Fiber K063778 Description The Spin-Loc Suture Anchor System consi… | 2006 |
| * | K063778 | Force Fiber Polyethylene Nonabsorbable SutureSummary page 1…K063479 Mitek Versalok K063478 Teleflex Medical Force Fiber K063778 Description The Spin-Loc Suture Anchor System consists of a PEEK polymer and stainless steel or cobalt chromium alloy suture anch… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120824 | 3.9MM Reelx STT Suture Anchor System | 2012 | 1 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K120824 (Stryker Corp., 2012) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K063479.
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. 2009, 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 Ross Creek Spin-Loc Suture Anchor System is intended to be used for soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is intended 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…
Read the full statement (109 words)
The Ross Creek Spin-Loc Suture Anchor System is intended to be used for soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is intended 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
Elbow
Biceps Tendon Reattachment
Foot and Ankle
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair
The Ross Creek Spin-Loc Suture Anchor System is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090530: Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090530
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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