510(k) · Cleared
ClearedKnotless Suture Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core Essence Orthopaedics · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 10, 2011 as substantially equivalent to K090128 (Core Essence Orthopaedics, Inc., 2009) and 1 other predicate after a 143-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Nov 10, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K961555 (1996). 34 ancestors in all, the oldest K904436 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 2 generations backK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
- 1 generation backK100457 Opus Speedscrew SystemArthrocare Corp. · 2010
- This deviceK111716 Knotless Suture Fixation SystemCore Essence Orthopaedics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −2 | K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 | Arthrocare Corp. | 2008 | — |
| −1 | K100457 | Opus Speedscrew System | Arthrocare Corp. | 2010 | — |
| 0 (this device) | K111716 | Knotless Suture Fixation System | Core Essence Orthopaedics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K090128 | Tac-Tite (TM)Summary page 2…dable, Soft Tissue and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code MBI Predicate Devices Securus Suture Anchors (K090 128) Opus® SpeedScrew Tm (K100457) Device Description Knotless Suture Fixation System includes threaded… | 2009 |
| * | K100457 | Opus Speedscrew SystemSummary page 2…040 Classification Panel: Orthopedic Product Code MBI Predicate Devices Securus Suture Anchors (K090 128) Opus® SpeedScrew Tm (K100457) Device Description Knotless Suture Fixation System includes threaded anchors used to facilitate fix… | 2010 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 34 ancestors have a recall of any class.
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. 2011, 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 Knotless Suture Fixation System is intended to secure soft tissue to bone of:
The Shoulder,
Bankart Repair
SLAP Lesion Repair
Acrornio-Clavicular Separation
Rotator Cuff Repair
Capsule Repair
Biceps Tenodesis
Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction
Bicep Tendon Reconstruction
Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction
Ulnar / Radial Collateral Ligament Reconstruction
Ankle/Foot Indications:
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair / Reconstruction
Hallux Valgus Reconstruction
Mid and Rear Foot Reconstruction
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/K111716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111716: Knotless Suture Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111716
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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