510(k) · Cleared
ClearedTornier, Piton Fixation Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 21, 2009 as substantially equivalent to K080335 (Tornier, Inc., 2008) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1992. 6 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921873 (1992). 22 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 4 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 3 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- 2 generations backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
- 1 generation backK080335 Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008
- This deviceK091870 Tornier, Piton Fixation Implant SystemTornier · 2009
- Descendant · cites it directly · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
- Descendant · 2 generations on · 0 of its ownK133777 Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110773Tornier Insite FT Suture AnchorTornier, Inc. · 2011 · cites it directly5descendants
- K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015 · 2 generations on2descendants
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 2 generations on1descendant
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 3 generations on0descendants
- K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −3 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| −2 | K070227 | Opus Magnum PI Knotless Fixation Device | Arthrocare Corp. | 2007 | — |
| −1 | K080335 | Tornier Cinch Knotless Fixation Implant System | Tornier, Inc. | 2008 | — |
| 0 (this device) | K091870 | Tornier, Piton Fixation Implant System | Tornier | 2009 | — |
| +1 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| +2 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| +2 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +3 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
| +2 | 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 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080335 | Tornier Cinch Knotless Fixation Implant SystemSummary page 1…Product code: MBI -Classll1 Predicate Device Tornier, Inc. CINCHT m Fixation Implant System. [510(k) Number K080335] Smith & Nephew, Inc.. TwinFix Ti 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors… | 2008 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…) Number K080335] Smith & Nephew, Inc.. TwinFix Ti 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors [510(k) K053344] 45 Description The PITON T M Fixation Implant S… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110773 | Tornier Insite FT Suture Anchor | 2011 | 5 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K110773 (Tornier, Inc., 2011) has gone furthest, with 5 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. 2009, 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 PITON™ Fixation Implant is intended for fixation of soft tissue to bone. The PITON™ 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…
Read the full statement (128 words)
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.
The PITON™ 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
Hip: Capsular Repair - Acetabular Labral Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091870: Tornier, Piton Fixation Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091870
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