510(k) · Cleared
ClearedTornier Insite (TM) FT Peek Knotless Suture Anchor
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 4, 2014 as substantially equivalent to K110773 (Tornier, Inc., 2011) and 1 other predicate after a 113-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Apr 4, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921873 (1992). 53 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 6 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 5 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 4 generations backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- 3 generations backK080335 Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008
- 2 generations backK091870 Tornier, Piton Fixation Implant SystemTornier · 2009
- 1 generation backK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- This deviceK133777 Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −6 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −5 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −4 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| −3 | K080335 | Tornier Cinch Knotless Fixation Implant System | Tornier, Inc. | 2008 | — |
| −2 | K091870 | Tornier, Piton Fixation Implant System | Tornier | 2009 | — |
| −1 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| 0 (this device) | K133777 | Tornier Insite (TM) FT Peek Knotless Suture Anchor | Tornier, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K110773 | Tornier Insite FT Suture AnchorSummary page 1…ivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Tornier, Inc. Incite FT Suture Anchor, K1 10773 and RaG Sports Medicine Knotless Anchor, KI 10230. 6. Device Description The Tomier Insite FT PEEK Knotless Suture Anchor i… | 2011 |
| * | K110230 | Rog Knotless Suture Anchor | 2011 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 53 ancestors have a recall of any class.
- 3 other devices also cite its predicate K110773.
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. 2014, 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 Tomicr Insite FT PEEK Knotiass Suture Anchors are intended for fixation of soft tissnoe to bone. The Tomier Insite PT PEEK Knotless Suture Anchors are intended for use in the rollowing applications. 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps Eenodesis, Acromnio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolsbral reconstruction. 2. Fool/Ankle: Lateral and Medial stabilization, Achilles tendon and…
Read the full statement (117 words)
The Tomicr Insite FT PEEK Knotiass Suture Anchors are intended for fixation of soft tissnoe to bone.
The Tomier Insite PT PEEK Knotless Suture Anchors are intended for use in the rollowing applications.
1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps Eenodesis, Acromnio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolsbral reconstruction.
2. Fool/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligannent repair, Hallux Valgus and Midioot reconstruction.
3. Knee: Medial collateral and Lateral collateral ligament repair. Patchear tendon and Posterior oblique ligament repair, liliotibial band tenodesis.
4. Hand/ Wrist Scapholumate ligament, Radial collateral ligament and Ulnm collateral ligament reconstructioa.
5. Elbow Biceps tendon reatlachmenl, Tennis elbow repair, Ulnar and Radial collateral ligsament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133777 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133777: Tornier Insite (TM) FT Peek Knotless Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133777
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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