510(k) · Cleared
ClearedKnotilus+ PEEK Knotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 24, 2023 as substantially equivalent to K101679 (Arthrex, Inc., 2010) and 1 other predicate after a 53-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 24, 2023
- Review
- 53 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K961555 (1996). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 2 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 1 generation backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- This deviceK232683 Knotilus+ PEEK Knotless AnchorStryker Endoscopy · 2023
- Descendant · cites it directly · 0 of its ownK261363 Y-Knotless™ Flex AnchorsCONMED Corporation · 2026
- Descendant · cites it directly · 0 of its ownK250544 Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy · 2025
Show all 9 generations
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 6 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 5 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 4 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 3 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 2 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 1 generation backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- This deviceK232683 Knotilus+ PEEK Knotless AnchorStryker Endoscopy · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −8 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −7 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −6 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −5 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −4 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −3 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −2 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −1 | K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy | 2023 | — |
| +1 | K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026 | — |
| +1 | K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K101679 | Arthrex Pushlock AnchorsSummary page 5…atory Class Class II Product Code MBI Predicate and Reference Devices: Name of Device Predicate - Arthrex PushLock Anchors, K101679 Predicate - Arthrex Short Suture Anchors, K151092 Reference - Stryker 3.9… | 2010 |
| * | K151092 | Arthrex Short Suture AnchorsSummary page 5…te and Reference Devices: Name of Device Predicate - Arthrex PushLock Anchors, K101679 Predicate - Arthrex Short Suture Anchors, K151092 Reference - Stryker 3.9MM ReelX STT Suture Anchor System, K120824… | 2016 |
| † | K120824 | 3.9MM Reelx STT Suture Anchor System | 2012 |
| † | K231093 | AlphaVent Suture Anchors | 2023 |
What descends from it? (2)
2 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 27 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K261363 (CONMED Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K101679.
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?
The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: 2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular…
Read the full statement (142 words)
The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:
2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction
Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand and /Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hip: Acetabular Labral Repair
2.4x8.9mm:
Hip: Acetabular Labral Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232683: Knotilus+ PEEK Knotless Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232683
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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