510(k) · Cleared
ClearedSpeedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile Drill Guidde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 9, 2011 as substantially equivalent to K090615 (Arthrocare Corp., 2009) after a 116-day review. Its family tree reaches back 4 generations to 1992. 4 later devices descend from it.
- Decided
- Aug 9, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921873 (1992). 12 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 3 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 2 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 1 generation backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
- This deviceK111044 Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped…ArthroCare Corporation · 2011
- Descendant · cites it directly · 1 of its ownK130196 Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill…Arthrocare Corp. · 2013
- Descendant · cites it directly · 1 of its ownK120943 Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill…ArthroCare Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK153313 SpeedLock Knotless Fixation SystemArthroCare Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK123240 Speedlock Hip Knotless Fixation ImplantArthroCare Corporation · 2013
Most influential descendants
Showing 4 of 4 · See all- K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp. · 2013 · cites it directly1descendant
- K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation · 2012 · cites it directly1descendant
- K153313SpeedLock Knotless Fixation SystemArthroCare Corporation · 2015 · 2 generations on0descendants
- K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −3 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −2 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −1 | K090615 | Opus Speedlock Knotless Fixation Device | Arthrocare Corp. | 2009 | 1 |
| 0 (this device) | K111044 | Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low… | ArthroCare Corporation | 2011 | — |
| +1 | K130196 | Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder… | Arthrocare Corp. | 2013 | — |
| +1 | K120943 | Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip… | ArthroCare Corporation | 2012 | — |
| +2 | K153313 | SpeedLock Knotless Fixation System | ArthroCare Corporation | 2015 | — |
| +2 | K123240 | Speedlock Hip Knotless Fixation Implant | ArthroCare Corporation | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K090615 | Opus Speedlock Knotless Fixation DeviceSummary page 1…e Model Name: Drill Guide, 3.5mm Low Profile Generic/Common Name: Drill Guide Predicate Devices Opus®)SpeedLock® K090615 (June 3, 20 10) Knotless Fixation Device Product Description The SpeedLock Knotless Fixation Device is a bone anchor system with… | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K130196 (Arthrocare Corp., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090615.
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 SpeedLock Knotless Fixation Device 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…
Read the full statement (91 words)
The SpeedLock Knotless Fixation Device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111044: Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile Drill Guidde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111044
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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