510(k) · Cleared
ClearedQ-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
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 Jul 9, 2026 as substantially equivalent to K172165 (ArthroCare Corporation, 2017) and 1 other predicate after a 28-day review. Its family tree reaches back 9 generations to 1999.
- Decided
- Jul 9, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K990088 (1999). 19 ancestors in all, the oldest K954808 (1996). No later device cites it as a predicate yet.
- Root · 9 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 5 generations between
- 3 generations backK133727 Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill…ArthroCare Corporation · 2014
- 2 generations backK172165 Q-Fix Suture AnchorArthroCare Corporation · 2017
- 1 generation backK241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID…Smith & Nephew, Inc. · 2024
- This deviceK261968 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and…Smith & Nephew, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 8 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 7 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 6 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 5 generations backK122336 Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide…Eleven Blade Solutions, Inc. · 2013
- 4 generations backK132513 Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and…ArthroCare Corporation · 2013
- 3 generations backK133727 Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill…ArthroCare Corporation · 2014
- 2 generations backK172165 Q-Fix Suture AnchorArthroCare Corporation · 2017
- 1 generation backK241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID…Smith & Nephew, Inc. · 2024
- This deviceK261968 Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and…Smith & Nephew, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −8 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −7 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −6 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −5 | K122336 | Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill… | Eleven Blade Solutions, Inc. | 2013 | — |
| −4 | K132513 | Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM… | ArthroCare Corporation | 2013 | — |
| −3 | K133727 | Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and… | ArthroCare Corporation | 2014 | — |
| −2 | K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | 2017 | — |
| −1 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue… | Smith & Nephew, Inc. | 2024 | — |
| 0 (this device) | 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 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172165 | Q-Fix Suture AnchorSummary page 5…Submission Number Clearance Date Q-FIX Suture Anchor ◊ K172165 (secondary predicate) 17 AUG 2017 Q-FIX Knotless All-Suture Anchors ◊… | 2017 |
| * | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…Summary page 5…K172165 (secondary predicate) 17 AUG 2017 Q-FIX Knotless All-Suture Anchors ◊ K241435 (primary predicate) 20 JUN 2024 Device Description The new 2.8mm Smith & Nephew Q-FIX◊ Knotless All… | 2024 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 19 ancestors have a recall of any class.
- 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. 2026, 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-FIX◊ Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications: Shoulder: • 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…
Read the full statement (116 words)
The Q-FIX◊ Knotless All-Suture Anchor is intended for use for soft tissue to bone fixation for the following indications:
Shoulder:
• 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
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/K261968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261968: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261968
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026