510(k) Report

510(k) · Cleared

Cleared

Tornier, Inc., Insite Suture Anchors

K083268510(k) TraditionalCleared Feb 12, 200999-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tornier, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Feb 12, 2009 as substantially equivalent to K003971 (Axya Medical, Inc., 2001) and 5 other predicates after a 99-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.

Decided
Feb 12, 2009
Review
99 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K003227 (2001). 13 ancestors in all, the oldest K963402 (1996). 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2001: 3 other ancestors2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2013: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedK003227 · Bio-Absorbable Corkscrew Model AR-1920B · Arthrex, Inc. · 2001K041698 · Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2004K051250 · Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2005K060970 · Axyaloop Nonabsorbable Bone Anchor · Axya Medical, Inc. · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K060970 · Axyaloop Nonabsorbable Bone Anchor · Axya Medical, Inc. · 2006 · recalledK051250 · Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2005K041698 · Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2004K003227 · Bio-Absorbable Corkscrew Model AR-1920B · Arthrex, Inc. · 20010
  1. Root · 4 generations backK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
  2. 3 generations backK041698 Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
  3. 2 generations backK051250 Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
  4. 1 generation backK060970 Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · Recalled
  5. This deviceK083268 Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009
  6. Descendant · cites it directly · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
  7. Descendant · 2 generations on · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
  8. Descendant · 2 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
  9. Descendant · 3 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
  10. Descendant · 2 generations on · 0 of its ownK133777 Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc. · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22014: 12015: 12020: 12026: 1
2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−4K003227Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc.2001—
−3K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.2004—
−2K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.2005—
−1K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.200621
0 (this device)K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.2009—
+1K110773Tornier Insite FT Suture AnchorTornier, Inc.2011—
+2K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.2015—
+2K201636Hercules Suture Anchor SystemIn2bones USA, LLC2020—
+3K253538TeKBrace Knotless AnchorTheramicro2026—
+2K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200010
200130
200210
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201410
201510
202010
202610
FIG. 1 — Lineage of K083268, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003971Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor
Summary page 1
…Predicate Devices Original Anchor Material Nominal Anchor Date Cleared 510(k) Notice Size (Diameter) K003971 Titanium 3mm March 21, 2001 K01 1912 Titanium 5mm…
Axya Medical, Inc.2001—
*K011912Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000
Summary page 1
…Date Cleared 510(k) Notice Size (Diameter) K003971 Titanium 3mm March 21, 2001 K01 1912 Titanium 5mm August 31, 2001 K052491 Titanium 6.5m…
Axya Medical, Inc.2001—
*K052491Axya Model 6500 Axyaloop Self-Tapping Bone Anchor
Summary page 1
…003971 Titanium 3mm March 21, 2001 K01 1912 Titanium 5mm August 31, 2001 K052491 Titanium 6.5mm October 7, 2005 K05 1983 PLLA Polymer 3m…
Axya Medical, Inc.200521
*K051983Model 3000 Axyaloop Bio-Absorbable Bone Anchor
Summary page 1
…1912 Titanium 5mm August 31, 2001 K052491 Titanium 6.5mm October 7, 2005 K05 1983 PLLA Polymer 3mm August 5, 2005 K041698 PLLA Polymer 5mm…
Axya Medical, Inc.200521
*K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor
Summary page 1
…52491 Titanium 6.5mm October 7, 2005 K05 1983 PLLA Polymer 3mm August 5, 2005 K041698 PLLA Polymer 5mm October 5, 2004 K151250 PLLA Polymer 6.5…
Axya Medical, Inc.2004—
Kept off the family treeK051250FDA’s K051250 is Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Axya Medical, Inc.2005—
*K060970Axyaloop Nonabsorbable Bone Anchor
Summary page 1
…K041698 PLLA Polymer 5mm October 5, 2004 K151250 PLLA Polymer 6.5mm June 9, 2005 K060970 Acetal Polymer 3,5 and 6.5mm July 5, 2006…
Axya Medical, Inc.200621

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110773Tornier Insite FT Suture AnchorTornier, Inc.20115
K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130
K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130

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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • 3 of the 13 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 MAI devices

MAI Fastener, Fixation, Biodegradable, 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 · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

Tornier(D Insite TM Suture Anchors are intended for use. for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction Foot/Ankle: Lateral and Medial-stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial…

Read the full statement (114 words)

Tornier(D Insite TM Suture Anchors are intended for use. for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction

Foot/Ankle: Lateral and Medial-stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Pateliar tendon and Posterior oblique ligament repair, lliotibial band tenodesis

HandNWrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

P'elvis: Bladder neck suspension for urinary incontinence due to urethral ·hypermobilitY or intrinsic sphincter deficiency infemales

Indications for use as stated in the FDA summary.

More from Tornier, Inc.

52 FDA decisions under this applicant name. See the company

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023
  • K220914Tornier Perform Humeral System – FractureTornier, Inc. · 2022

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K083268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083268: Tornier, Inc., Insite Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083268

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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