510(k) · Cleared
ClearedTornier Cinch Knotless Fixation Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 23, 2008 as substantially equivalent to K073226 (C2m Medical, Inc., 2007) and 2 other predicates after a 76-day review. Its family tree reaches back 4 generations to 1992. 7 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K921873 (1992). 17 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 3 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 2 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 1 generation backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- This deviceK080335 Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK091870 Tornier, Piton Fixation Implant SystemTornier · 2009
- Descendant · 2 generations on · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 4 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091870Tornier, Piton Fixation Implant SystemTornier · 2009 · cites it directly6descendants
- K110773Tornier Insite FT Suture AnchorTornier, Inc. · 2011 · 2 generations on5descendants
- K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015 · 3 generations on2descendants
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 3 generations on1descendant
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −3 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −2 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −1 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| 0 (this device) | K080335 | Tornier Cinch Knotless Fixation Implant System | Tornier, Inc. | 2008 | — |
| +1 | K091870 | Tornier, Piton Fixation Implant System | Tornier | 2009 | — |
| +2 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| +3 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| +3 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +4 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073226 | Cinch Knotless Fixation Implant SystemSummary page 1…Product code: MBI - 4aI§s Predicate Device C2M Medical, Inc. CINCH TM Knotless Fixation Implant System. [510(k) Number K073226] ArthroCare Corp. Opus® Magnum T M PI Knotless Fixation Device [510(k) K070227] Arthrex, I… | 2007 |
| * | K070227 | Opus Magnum PI Knotless Fixation DeviceSummary page 1…nt System. [510(k) Number K073226] ArthroCare Corp. Opus® Magnum T M PI Knotless Fixation Device [510(k) K070227] Arthrex, Inc. Arthrex Corkscrew FT [510(K) K0061665] Mitek Products Mini Q… | 2007 |
| * | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTSummary page 1…Magnum T M PI Knotless Fixation Device [510(k) K070227] Arthrex, Inc. Arthrex Corkscrew FT [510(K) K0061665] Mitek Products Mini QuickAnchor® Plus [510(K) K002487]… | 2006 |
| Kept off the family tree | K002487 | Mini QuickAnchor® Plus Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Inc. Arthrex Corkscrew FT [510(K) K0061665] Mitek Products Mini QuickAnchor® Plus [510(K) K002487] 38 Description The CINCH T M Knotless Fixation Implant System i… |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091870 | Tornier, Piton Fixation Implant System | 2009 | 6 |
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 4 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K091870 (Tornier, 2009) has gone furthest, with 6 descendants of its own.
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 Tornier CINCH TM Knotless Fixation Implant is intended for fixation of soft tissue to bone. The CINCH TM Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus…
Read the full statement (124 words)
The Tornier CINCH TM Knotless Fixation Implant is intended for fixation of soft tissue to bone.
The CINCH TM Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080335 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080335: Tornier Cinch Knotless Fixation Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080335
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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