510(k) · Cleared
ClearedKnotilus Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T.A.G. Medical Products Corporation, Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 2, 2012 as substantially equivalent to K070882 (Stryker Endoscopy, 2007) after a 115-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 2, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961555 (1996). 12 ancestors in all. 3 later devices descend from it, 3 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 backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 1 generation backK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007
- This deviceK113297 Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK210498 Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK202178 VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025 · cites it directly0descendants
- K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · cites it directly0descendants
- K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd. · 2020 · cites it directly0descendants
View 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 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −1 | K070882 | Stryker Peek Twinloop Tac | Stryker Endoscopy | 2007 | — |
| 0 (this device) | K113297 | Knotilus Anchor System | T.A.G. Medical Products Corporation, Ltd. | 2012 | — |
| +1 | K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +1 | K210498 | Betta Link Knotless Implant System | T.A.G. Medical Products Corporation, Ltd. | 2021 | 1 |
| +1 | K202178 | VersaLoop Anchor System | T.A.G. Medical Products Corporation, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K070882 | Stryker Peek Twinloop TacSummary page 1…cessories, class 11device Name & code: (product code LYT ;Regulation number 21 CFR 888.3030) 3. Predicate Stryker Endoscopy PEEK TWINLOOP TAG - K070882 Devices: 4. Description: The Knotilus Anchor System consists of: *Knotilus Anchor - an… | 2007 |
What descends from it? (3)
3 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 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K242477 (Signature Orthopaedics Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070882.
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 Knotilus'm Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113297: Knotilus Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113297
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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