510(k) · Cleared
ClearedQ-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eleven Blade Solutions, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 9, 2013 as substantially equivalent to K063778 (Teleflex Medical, 2007) after a 160-day review. Its family tree reaches back 4 generations to 1999. 7 later devices descend from it.
- Decided
- Jan 9, 2013
- Review
- 160 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990088 (1999). 14 ancestors in all, the oldest K954808 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 1 generation backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- This deviceK122336 Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide…Eleven Blade Solutions, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK132513 Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and…ArthroCare Corporation · 2013
- Descendant · 2 generations on · 5 of its ownK133727 Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill…ArthroCare Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK172165 Q-Fix Suture AnchorArthroCare Corporation · 2017
- Descendant · 4 generations on · 1 of its ownK241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID…Smith & Nephew, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261968 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and…Smith & Nephew, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132513Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM…ArthroCare Corporation · 2013 · cites it directly6descendants
- K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation · 2014 · 2 generations on5descendants
- K172165Q-Fix Suture AnchorArthroCare Corporation · 2017 · 3 generations on4descendants
- K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…Smith & Nephew, Inc. · 2024 · 4 generations on1descendant
- K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…Smith & Nephew, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −3 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −2 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −1 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| 0 (this device) | K122336 | Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill… | Eleven Blade Solutions, Inc. | 2013 | — |
| +1 | K132513 | Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM… | ArthroCare Corporation | 2013 | — |
| +2 | K133727 | Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and… | ArthroCare Corporation | 2014 | — |
| +3 | K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | 2017 | — |
| +4 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue… | Smith & Nephew, Inc. | 2024 | — |
| +4 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue… | Smith & Nephew, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101045 | Biomet Juggerknot Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K063778 | Force Fiber Polyethylene Nonabsorbable SutureSummary page 1…10O(k) Number I5 Biomet Sports Medicine Juggerknot Soft Anchor Ki 10145 Teleflex Medical ForceFiber K063778 Description The Q-FixTM Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding again… | 2007 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132513 | Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM… | 2013 | 6 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K132513 (ArthroCare Corporation, 2013) has gone furthest, with 6 descendants of its own.
- 16 other devices also cite its predicate K063778.
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. 2013, 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 Eleven Blade Solutions, Inc., Q-FixTM' Suture Anchor System is intended to be used for Soft tissue to bone fixation for: Shoulder Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis Foot and Ankle Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or…
Read the full statement (116 words)
The Eleven Blade Solutions, Inc., Q-FixTM' Suture Anchor System is intended to be used for Soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule Closure
Hand and Wrist
Collateral ligament repair. Sacpholunate ligament reconstruction, Tendlon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122336: Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122336
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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