510(k) · Cleared
ClearedTornier Insite FT 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 Jun 2, 2011 as substantially equivalent to K083268 (Tornier, Inc., 2009) and 2 other predicates after a 73-day review. Its family tree reaches back 6 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 2, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921873 (1992). 38 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 5 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 4 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 3 generations backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- 2 generations backK080335 Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008
- 1 generation backK091870 Tornier, Piton Fixation Implant SystemTornier · 2009
- This deviceK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
- Descendant · cites it directly · 0 of its ownK133777 Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK132632 Tornier Insite FT Suture Anchor with NeedlesTornier, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015 · cites it directly2descendants
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · cites it directly1descendant
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 2 generations on0descendants
- K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014 · cites it directly0descendants
- K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −5 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −4 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −3 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| −2 | K080335 | Tornier Cinch Knotless Fixation Implant System | Tornier, Inc. | 2008 | — |
| −1 | K091870 | Tornier, Piton Fixation Implant System | Tornier | 2009 | — |
| 0 (this device) | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| +1 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| +1 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +2 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
| +1 | K133777 | Tornier Insite (TM) FT Peek Knotless Suture Anchor | Tornier, Inc. | 2014 | — |
| +1 | K132632 | Tornier Insite FT Suture Anchor with Needles | Tornier, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K083268 | Tornier, Inc., Insite Suture AnchorsSummary page 2…se and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: * TORNIER, INC., INSITE SUTURE ANCHORS K083268 * TORNIER, PITON FIXATION IMPLANT SYSTEM K091870 * SMITH & NEPHEW INC., ENDOSCOPY DIVISION BIORAPTOR 2.… | 2009 |
| * | K091870 | Tornier, Piton Fixation Implant SystemSummary page 2…egally marketed devices in commercial distribution: * TORNIER, INC., INSITE SUTURE ANCHORS K083268 * TORNIER, PITON FIXATION IMPLANT SYSTEM K091870 * SMITH & NEPHEW INC., ENDOSCOPY DIVISION BIORAPTOR 2.3 PK SUTURE ANCHOR K071586 6) Device Descripti… | 2009 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 2…083268 * TORNIER, PITON FIXATION IMPLANT SYSTEM K091870 * SMITH & NEPHEW INC., ENDOSCOPY DIVISION BIORAPTOR 2.3 PK SUTURE ANCHOR K071586 6) Device Description The Tornier InsiteiM FT Suture Anchor consists of a bone implant device intended for the fixation… | 2007 |
What descends from it? (5)
4 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 19 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K150715 (Tornier, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K083268.
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 Tornier InsitTM FT Suture Anchors are intended for fixation of soft tissue to bone. The Tornier InsiteTm FT Suture Anchors are intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair…
Read the full statement (112 words)
The Tornier InsitTM FT Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier InsiteTm FT Suture Anchors are intended for use in the following applications:
1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, H-allux Valgus and Midfoot Reconstruction.
3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110773: Tornier Insite FT Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110773
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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