510(k) · Cleared

Cleared

2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors

K150715510(k) TraditionalCleared Jul 28, 2015131-day reviewClass II21 CFR 888.3040

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

Tornier, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 28, 2015 as substantially equivalent to K110773 (Tornier, Inc., 2011) and 1 other predicate after a 131-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.

Decided: Jul 28, 2015
Review: 131 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 7 generations to K921873 (1992). 42 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

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 deviceK150715 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

Most influential descendants

Showing 2 of 2 · See all

K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · cites it directly1descendant
K253538TeKBrace Knotless AnchorTheramicro · 2026 · 2 generations on0descendants

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)	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	—

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	5	0
2006	5	0
2007	3	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2026	1	0

FIG. 1 — Lineage of K150715, 1992–2026Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K110773	Tornier Insite FT Suture Anchor Summary page 4 …one fixation fastener Regulatory Class: Class II Product Code: MBI III. Predicate Device Information Tornier Insite™ FT PEEK Knotless Suture Anchor K110773 and Smith and Nephew 2.0PK Suture Anchor K081511. IV. Device Description The Insite™ FT PEEK Suture Anchor is a bone implan…	Tornier, Inc.	2011	—
*	K081511	2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S Summary page 4 …ss II Product Code: MBI III. Predicate Device Information Tornier Insite™ FT PEEK Knotless Suture Anchor K110773 and Smith and Nephew 2.0PK Suture Anchor K081511. IV. Device Description The Insite™ FT PEEK Suture Anchor is a bone implant device intended for the fixation of soft tissue…	Smith & Nephew, Inc.	2008	—

Also cleared against K110773: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K201636	Hercules Suture Anchor System	In2bones USA, LLC	2020	1

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 23 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
8 of the 42 ancestors have a recall of any class.
Of its descendants, K201636 (In2bones USA, LLC, 2020) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K110773.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)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 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder. The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite™ FT PEEK 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…

Read the full statement (132 words)

The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder.

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

The Tornier Insite™ FT PEEK 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/K150715 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150715: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150715

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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