510(k) · Cleared
ClearedTwinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors
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 Jan 31, 2012 as substantially equivalent to K110545 (Smith & Nephew, Inc., 2011) and 4 other predicates after a 153-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it.
- Decided
- Jan 31, 2012
- Review
- 153 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K961555 (1996). 26 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 4 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- 3 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- 2 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
- 1 generation backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- This deviceK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK202153 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK253010 Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · cites it directly6descendants
- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 2 generations on1descendant
- K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020 · 2 generations on1descendant
- K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −4 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −3 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −2 | K093228 | Smith & Nephew Twinfix Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100159 | Smith and Nephew Twinfix Ultra TI Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 4 |
| 0 (this device) | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | Smith & Nephew, Inc. | 2012 | — |
| +1 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
| +1 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +2 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022 | — |
| +2 | K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2020 | — |
| +3 | K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | 2011 |
| * | K100159 | Smith and Nephew Twinfix Ultra TI Suture AnchorSummary page 1…commercial distribution: The Smith & Nephew Next Generation Fully Threaded Suture Anchor (NGFTSA) (KI 10545), Smith & Nephew TWINFIX Ultra Ti Suture Anchor (K100159), Smith & Nephew TWINFIX Ultra PK Suture Anchor (K093228), Smith & Nephew TWINFIX Ultra HA Suture Anchor (K093844) and… | 2010 |
| * | K093228 | Smith & Nephew Twinfix Ultra PK Suture AnchorSummary page 1…lly Threaded Suture Anchor (NGFTSA) (KI 10545), Smith & Nephew TWINFIX Ultra Ti Suture Anchor (K100159), Smith & Nephew TWINFIX Ultra PK Suture Anchor (K093228), Smith & Nephew TWINFIX Ultra HA Suture Anchor (K093844) and Arthrex Corkscrew Suture Anchor (K061 665).… | 2009 |
| * | K093844 | Smith & Nephew Twinfix Ultra HA Suture AnchorSummary page 1…th & Nephew TWINFIX Ultra Ti Suture Anchor (K100159), Smith & Nephew TWINFIX Ultra PK Suture Anchor (K093228), Smith & Nephew TWINFIX Ultra HA Suture Anchor (K093844) and Arthrex Corkscrew Suture Anchor (K061 665).… | 2010 |
| * | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTSummary page 1…00159), Smith & Nephew TWINFIX Ultra PK Suture Anchor (K093228), Smith & Nephew TWINFIX Ultra HA Suture Anchor (K093844) and Arthrex Corkscrew Suture Anchor (K061 665). ) (Z15Z& 13) E. Descriptio… | 2006 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 26 ancestors have a recall of any class.
- Of its descendants, K152566 (Smith & Nephew, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K110545.
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. 2012, 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 Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs; SLAP lesion repairs; Acromnioclavicular separation repairs; Rotator cuff tear repairs; Capsular shift or capsulolabral reconstructions; Biceps tenodesis; Deltoid repairs. Foot and Ankle: Hallux valgus repairs; Medial or lateral instability…
Read the full statement (111 words)
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Bankart lesion repairs; SLAP lesion repairs; Acromnioclavicular separation repairs; Rotator cuff tear repairs; Capsular shift or capsulolabral reconstructions; Biceps tenodesis; Deltoid repairs.
Foot and Ankle: Hallux valgus repairs; Medial or lateral instability repairs/reconstructions; Achilles tendon repairs/reconstructions; Midfoot reconstructions; Metatarsal ligament/tendon repairs/reconstructions.
Elbow: Ulnar or radial collateral ligament reconstructions; Lateral epicondylitis repair; Biceps tendon reattachment.
Knee: Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament; Iliotibial band tenodesis; Patellar realignment and tendon repairs: Vastus medialis oblicjous advancement.
Hip: Abductor tendon repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112526
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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