510(k) · Cleared
ClearedTornier Insite FT Suture Anchor with Needles
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 Sep 19, 2013 as substantially equivalent to K110773 (Tornier, Inc., 2011) and 1 other predicate after a 28-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Sep 19, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921873 (1992). 39 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 deviceK132632 Tornier Insite FT Suture Anchor with NeedlesTornier, Inc. · 2013
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) | 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 |
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…ication Name: Product Code: MB! 21 CER 888.3040 Legally Marketed Device to K 110773 - Tomier Insite FT Suture Anchor, cleared 2 June 2011 Which Your Firm Is 1K083268 - Tomrier, Inc… | 2011 |
| * | K083268 | Tornier, Inc., Insite Suture AnchorsSummary page 1…0 Legally Marketed Device to K 110773 - Tomier Insite FT Suture Anchor, cleared 2 June 2011 Which Your Firm Is 1K083268 - Tomrier, Inc., Insite Suture Anchor, cleared 12 February 2009 Claiming Equivalence: Description of Th… | 2009 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 39 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. 2013, 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 Insite FT Suture Anchor is intended for fixation of soft tissue to bone. The Tornier Insite FT Suture Anchor is 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, Hallux Valgus…
Read the full statement (112 words)
The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone.
The Tornier Insite FT Suture Anchor is 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, Hallux Valgus and Midfoot Reconstruction.
3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial 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/K132632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132632: Tornier Insite FT Suture Anchor with Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132632
Report an extraction error
Are you the manufacturer?
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