510(k) · Cleared

Cleared

Tornier Insite FT Biocomposite Suture Anchor

K122635510(k) TraditionalCleared May 13, 2013257-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 May 13, 2013 as substantially equivalent to K083268 (Tornier, Inc., 2009) and 2 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1996.

Decided: May 13, 2013
Review: 257 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K961555 (1996). 20 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
1 generation backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
This deviceK122635 Tornier Insite FT Biocomposite Suture AnchorTornier, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−4	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−3	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−2	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
−1	K071177	Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…	Arthrex, Inc.	2007	—
0 (this device)	K122635	Tornier Insite FT Biocomposite Suture Anchor	Tornier, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
2000	1	0
2001	4	0
2002	1	0
2004	1	0
2005	3	0
2006	1	0
2009	1	0

FIG. 1 — Lineage of K122635, 1996–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K083268	Tornier, Inc., Insite Suture Anchors Summary page 1 …nded Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: " TORNIER, INC., INSITE BIO-ABSORBABLE SUTURE ANCHOR K083268 * ARTHREX, INC., BIO-CORKSCREW FT SUTURE ANCHOR K061 863 -ARTHREX, INC., BIO-COMPOSITE CORKSCREW FT SUTURE ANCHOR K071 177 ===…	Tornier, Inc.	2009	—
*	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family Summary page 1 …llowing legally marketed devices in commercial distribution: " TORNIER, INC., INSITE BIO-ABSORBABLE SUTURE ANCHOR K083268 * ARTHREX, INC., BIO-CORKSCREW FT SUTURE ANCHOR K061 863 -ARTHREX, INC., BIO-COMPOSITE CORKSCREW FT SUTURE ANCHOR K071 177 K122635 (…	Arthrex, Inc.	2006	—
*	K071177	Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak… Summary page 1 …IER, INC., INSITE BIO-ABSORBABLE SUTURE ANCHOR K083268 * ARTHREX, INC., BIO-CORKSCREW FT SUTURE ANCHOR K061 863 -ARTHREX, INC., BIO-COMPOSITE CORKSCREW FT SUTURE ANCHOR K071 177 K122635 (Page 2 of 3) 6. Device Description The Tornier lnsiteTM FT Biocom…	Arthrex, Inc.	2007	—

Also cleared against K083268: 2 other devices →

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 17 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
5 of the 20 ancestors have a recall of any class.
2 other devices also cite its predicate K083268.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The Tornier Insite TM FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite TM FT Biocomposite 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…

Read the full statement (116 words)

The Tornier Insite TM FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.

The Tornier Insite TM FT Biocomposite 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, Hallux 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/K122635 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122635: Tornier Insite FT Biocomposite 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/K122635

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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