510(k) · Cleared
ClearedQ-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 20, 2024 as substantially equivalent to K172165 (ArthroCare Corporation, 2017) after a 30-day review. Its family tree reaches back 8 generations to 1999. 1 later device descends from it.
- Decided
- Jun 20, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K990088 (1999). 18 ancestors in all, the oldest K954808 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 7 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 6 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 5 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 4 generations backK122336 Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide…Eleven Blade Solutions, Inc. · 2013
- 3 generations backK132513 Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and…ArthroCare Corporation · 2013
- 2 generations backK133727 Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill…ArthroCare Corporation · 2014
- 1 generation backK172165 Q-Fix Suture AnchorArthroCare Corporation · 2017
- This deviceK241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID…Smith & Nephew, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261968 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and…Smith & Nephew, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…Smith & Nephew, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −7 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −6 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −5 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −4 | K122336 | Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill… | Eleven Blade Solutions, Inc. | 2013 | — |
| −3 | 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 | — |
| −1 | K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | 2017 | — |
| 0 (this device) | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue… | Smith & Nephew, Inc. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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? (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.
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 |
|---|---|---|---|
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE… | 2026 | 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 25 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K261968 (Smith & Nephew, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K172165.
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. 2024, 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 Q-FIXO Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications: Shoulder: * Bankart lesion repair * SLAP lesion repair * Acromio-clavicular repair * Capsular shift/capsulolabral reconstruction * Deltoid repair * Rotator cuff tear repair * Biceps tenodesis Foot & Ankle: * Medial/Lateral repair and reconstruction * Midfoot and forefoot repair * Hallux valgus reconstruction * Metatarsal…
Read the full statement (127 words)
The Q-FIXO Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications:
Shoulder:
* Bankart lesion repair
* SLAP lesion repair
* Acromio-clavicular repair
* Capsular shift/capsulolabral reconstruction
* Deltoid repair
* Rotator cuff tear repair
* Biceps tenodesis
Foot & Ankle:
* Medial/Lateral repair and reconstruction
* Midfoot 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: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament
* Iliotibial band tenodesis (IBT)
* Patellar tendon repair
* Vastus medialis obliquus advancement (VMO)
* Joint capsule closure
Hip:
*Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241435: Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241435
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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