510(k) · Cleared

Cleared

Statak Soft Tissue Attachment Device

K962397510(k) TraditionalCleared Aug 27, 199667-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

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

Cleared on Aug 27, 1996 as substantially equivalent to K926384 (Zimmer, Inc., 1993) and 3 other predicates after a 67-day review. Its family tree reaches back 1 generation to 1990. 531 later devices descend from it.

Decided: Aug 27, 1996
Review: 67 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K904436 (1990). 4 ancestors in all. 531 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
This deviceK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
Descendant · cites it directly · 393 of its ownK973015 Multitak SS Suture SystemBonutti Research · 1997
Descendant · 2 generations on · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
Descendant · 3 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
Descendant · 4 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 5 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005

Showing 5 of 531 descendants. See all descendants

Descendants cleared per year

1997high 55 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 531 · See all

K973015Multitak SS Suture SystemBonutti Research · 1997 · cites it directly393descendants
K990156Multitak SS ButtonsBonutti Research · 1999 · 2 generations on336descendants
K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 3 generations on309descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 4 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 5 generations on217descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904436	Quickanchor (TM)	Mitek Surgical Products, Inc.	1990	—
0 (this device)	K962397	Statak Soft Tissue Attachment Device	Zimmer, Inc.	1996	—
+1	K973015	Multitak SS Suture System	Bonutti Research	1997	—
+2	K990156	Multitak SS Buttons	Bonutti Research	1999	—
+3	K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	2004	—
+4	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+5	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	2	0
1999	4	0
2001	1	0
2002	4	0
2003	2	0
2004	4	0
2005	4	0
2006	7	0
2007	6	0
2008	9	0
2009	11	0
2010	7	0
2011	14	0
2012	8	0
2013	18	0
2014	24	0
2015	14	0
2016	12	0
2017	26	0
2018	19	0
2019	34	0
2020	33	0
2021	31	0
2022	33	0
2023	45	0
2024	50	0
2025	55	0
2026	52	0

FIG. 1 — Lineage of K962397, 1990–2026Source: 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? (4)

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
*	K926384	Statak & Mini-Statak Soft Tissue Attachment Device Summary page 1 …ft Tissue Anchor Classification Name: 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener Predicate Devices: * Statak® Soft Tissue Attachment Device, K926384 * GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877 * Mini Anchor, manufactured by Mitek Surgical Pro…	Zimmer, Inc.	1993	—
*	K953877	Mitek Gii Anchor Summary page 1 …tallic Bone Fixation Fastener Predicate Devices: * Statak® Soft Tissue Attachment Device, K926384 * GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877 * Mini Anchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436 16 %Z% A Bristol-Myers Squiblb Company ===…	Mitek Surgical Products, Inc.	1995	—
*	K930892	Mitek Mini Anchor, Modification Summary page 1 …Attachment Device, K926384 * GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877 * Mini Anchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436 16 %Z% A Bristol-Myers Squiblb Company Device Description: The Statak Soft Tissue Attachment Devic…	Mitek Surgical Products, Inc.	1994	—
*	K904436	Quickanchor (TM) Summary page 1 …Device, K926384 * GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877 * Mini Anchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436 16 %Z% A Bristol-Myers Squiblb Company Device Description: The Statak Soft Tissue Attachment Device anchor has…	Mitek Surgical Products, Inc.	1990	—

Also cleared against K926384: 8 other devices →

What descends from it? (531)

See all 531

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

Number	Device	Applicant	Decided	Descendants
K973015	Multitak SS Suture System	Bonutti Research	1997	393
K972783	Biofix Biodegradable Threaded Suture Anchor	Bionx Implants, Inc.	1998	166
K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	7
K971144	Multitak SS Suture System	Bonutti Research	1997	0

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?

None of the 4 ancestors has a recall.
Of its descendants, K973015 (Bonutti Research, 1997) has gone furthest, with 393 descendants of its own.
8 other devices also cite its predicate K926384.

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.

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 devices are intended for soft tissue-to-bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separation repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallus…

Read the full statement (106 words)

The devices are intended for soft tissue-to-bone suture fixation for the following indications:

Shoulder

- Bankart lesion repairs

- SLAP lesion repairs

- Acromio-clavicular separation repairs

- Rotator cuff tear repairs

- Capsular shift or capsulolabral reconstructions

- Biceps tenodesis

- Deltoid repairs

Foot and Ankle

- Medial or lateral instability repairs/reconstructions

- Achilles tendon repairs/reconstructions

- Midfoot reconstructions

- Hallus valgus reconstructions

Elbow, Wrist, and Hand

Scapholunate ligament reconstructions

Ulnar or radial collateral ligament reconstructions

Tennis elbow repair

Biceps tendon reattachment

Knee

- Extra-capsular repairs:

-- Medial collateral ligament

-- Lateral collateral ligament

-- Posterior oblique ligament

- Tliotibial band tenodesis

- Patellar tendon repairs

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962397: Statak Soft Tissue Attachment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962397

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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