510(k) · Cleared
ClearedKnotilus+ Biocomposite Knotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on May 23, 2025 as substantially equivalent to K232683 (Stryker Endoscopy, 2023) and 3 other predicates after an 87-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- May 23, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K961555 (1996). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations between
- 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 1 generation backK201786 Arthrex Mini Hip PushLockArthrex, Inc. · 2020
- This deviceK250544 Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy · 2025
Show all 10 generations
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 7 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 6 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 5 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 4 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 1 generation backK201786 Arthrex Mini Hip PushLockArthrex, Inc. · 2020
- This deviceK250544 Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −9 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −8 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −7 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −6 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −5 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −4 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −3 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −2 | K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 | — |
| −1 | K201786 | Arthrex Mini Hip PushLock | Arthrex, Inc. | 2020 | — |
| 0 (this device) | 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 |
| 2023 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (4)
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 |
|---|---|---|---|
| * | K232683 | Knotilus+ PEEK Knotless Anchor Our reading of the summary gave K232863, FDA’s number for Radiant Renewal Skincare Wand (HD-15, HD-15A) (Shenzhen Kaiyan Medical Equipment Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Knotilus+ PEEK Knotless Anchor”. | 2023 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 5…Primary Predicate - Knotilus+ PEEK Knotless Anchor, K232863 (MBI) Secondary Predicate - Arthrex PushLock Anchors, K101679 (MAI) Secondary Predicate - Arthrex Short Suture Anchors, K151092… | 2010 |
| * | K151092 | Arthrex Short Suture AnchorsSummary page 5…Secondary Predicate - Arthrex PushLock Anchors, K101679 (MAI) Secondary Predicate - Arthrex Short Suture Anchors, K151092 (MBI)/K201786 (MAI) Reference - Stryker AlphaVent Suture Anchors, K231093 (MA… | 2016 |
| * | K201786 | Arthrex Mini Hip PushLockSummary page 5…ck Anchors, K101679 (MAI) Secondary Predicate - Arthrex Short Suture Anchors, K151092 (MBI)/K201786 (MAI) Reference - Stryker AlphaVent Suture Anchors, K231093 (MAI, MBI)… | 2020 |
| † | K231093 | AlphaVent Suture Anchors | 2023 |
| † | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | 2018 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K232683.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Knotilus+ Biocomposite 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…
Read the full statement (142 words)
The Knotilus+ Biocomposite 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250544: Knotilus+ Biocomposite 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/K250544
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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