510(k) · Cleared
ClearedSpeedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide Model OM-75
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 20, 2011 as substantially equivalent to K101437 (Arthrocare Corp., 2010) after a 62-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jul 20, 2011
- Review
- 62 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921873 (1992). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 4 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 3 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 2 generations backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- 1 generation backK101437 Speedfix Suture SystemArthrocare Corp. · 2010
- This deviceK111399 Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp…Arthrocare Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −3 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −2 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| −1 | K101437 | Speedfix Suture System | Arthrocare Corp. | 2010 | — |
| 0 (this device) | K111399 | Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped… | Arthrocare Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K101437 | Speedfix Suture SystemSummary page 1…e Model Name: Drill Guide, 3.5mm Low Profile Generic/Common Name: Drill Guide Predicate Devices SpeedFix Suture Implant K101437 (October 29, 2010) Product Description The Speed~ix Suture System is a bone anchor system with inserter handle designed for spec… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K101437.
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. 2011, 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 SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow…
Read the full statement (90 words)
The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator
cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and
midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior
oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular
reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111399: Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide Model OM-75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111399
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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