510(k) · Cleared
ClearedTwinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SL
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 Feb 20, 2013 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 20, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961555 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- This deviceK123425 Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with…Smith & Nephew, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −2 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −1 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K123425 | Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SL | Smith & Nephew, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…s, SLis substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K053344 Bioraptor Suture Anchor, TWINFIX Ti 2.8mm & TWINFIX 3.5mm (Cleared February 23, 2006)… | 2006 |
| * | K972326 | Peba Anchor/Suture CombinationSummary page 1…l distribution: K053344 Bioraptor Suture Anchor, TWINFIX Ti 2.8mm & TWINFIX 3.5mm (Cleared February 23, 2006) K972326 PEBA Anchor/Suture Combination (Cleared February 6,1998) D. -iceDecrpt.n The Smit… | 1998 |
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 17 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 15 other devices also cite its predicate K053344.
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?
Smith &Nephew TWINFIX* Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications. Shoulder Bankari lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs Foot and Ankle Hallux valgus reconstruction, Medial or…
Read the full statement (115 words)
Smith &Nephew TWINFIX* Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.
Shoulder
Bankari lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs
Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions
Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123425: Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123425
Report an extraction error
Are you the manufacturer?
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