510(k) · Cleared
ClearedQ-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
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 Aug 9, 2023 as substantially equivalent to K172165 (ArthroCare Corporation, 2017) and 1 other predicate after an 89-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Aug 9, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K990088 (1999). 25 ancestors in all, the oldest K954808 (1996). No later device cites it as a predicate yet.
- 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 deviceK231376 Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With…Smith & Nephew, Inc. · 2023
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) | K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles… | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 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 4…Product Code MBI CFR Section 21 CFR 888.3040 3 PREDICATE DEVICE(S) Primary Predicate Q-FIX ® Suture Anchor (K172165) Secondary Predicate Device RAPTORMITE 3.0 PK Suture Anchor (K071586) Reference Device Bior… | 2017 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 4…PREDICATE DEVICE(S) Primary Predicate Q-FIX ® Suture Anchor (K172165) Secondary Predicate Device RAPTORMITE 3.0 PK Suture Anchor (K071586) Reference Device Bioraptor Knotless Suture Anchor (K093428)… | 2007 |
| † | K093428 | Smith & Nephew Knotless Instability Anchor | 2009 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 8 of the 25 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. 2023, 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?
Q-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231376: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231376
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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