510(k) · Cleared
Cleared2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S
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 26, 2008 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 2 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 26, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K961555 (1996). 9 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- This deviceK081511 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| 0 (this device) | K081511 | 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S | Smith & Nephew, Inc. | 2008 | — |
| +1 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| +2 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +3 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…e Anchor S are substantially equivalent to the following legally marketed device in commercial distribution: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor cleared in K07 1586 and Arthrex Mini BioSuture TakTM cleared in K050749/K061 863.… | 2007 |
| * | K050749 | Arthrex Tak FamilySummary page 1…ing legally marketed device in commercial distribution: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor cleared in K07 1586 and Arthrex Mini BioSuture TakTM cleared in K050749/K061 863. Smith & Nephew, INC… | 2005 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…lly marketed device in commercial distribution: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor cleared in K07 1586 and Arthrex Mini BioSuture TakTM cleared in K050749/K061 863. Smith & Nephew, INC… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | 2015 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K150715 (Tornier, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 22 other devices also cite its predicate K071586.
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. 2008, 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 2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis. Foot/Ankle: Hallux valgus repairs, Medial or lateral…
Read the full statement (121 words)
The 2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction, Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and 1lloiotibial band tenodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081511: 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081511
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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