510(k) Report

510(k) · Cleared

Cleared

Multitak SS Suture System

K973015510(k) TraditionalCleared Oct 9, 199757-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

Bonutti Research · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 9, 1997 as substantially equivalent to K934183 (Apogee Medical Products, Inc., 1996) and 3 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1990. 393 later devices descend from it.

Decided
Oct 9, 1997
Review
57 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K904436 (1990). 7 ancestors in all. 393 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2008: 6 descendants cleared2010: 2 descendants cleared1999: 2 descendants cleared2007: 3 descendants cleared2017: 22 descendants cleared2011: 9 descendants cleared2020: 30 descendants cleared2013: 16 descendants cleared2004: 2 descendants cleared2003: 1 descendant cleared2001: 1 descendant cleared2006: 4 descendants cleared2009: 4 descendants cleared2005: 3 descendants cleared2012: 5 descendants cleared2019: 30 descendants cleared2015: 11 descendants cleared2016: 10 descendants cleared2014: 19 descendants cleared2023: 32 descendants cleared2018: 17 descendants cleared2024: 36 descendants cleared2025: 34 descendants cleared2021: 28 descendants cleared2022: 26 descendants cleared2026: 40 descendants clearedK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 10 descendants3 generations forward: 32 descendants4 generations forward: 70 descendants5 generations forward: 73 descendants6 generations forward: 68 descendants7 generations forward: 62 descendants8 generations forward: 38 descendants9 generations forward: 16 descendants10 generations forward: 8 descendants11 generations forward: 6 descendants12 generations forward: 3 descendants13 generations forward: 2 descendants K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 19900+5+10
  1. Root · 2 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 1 generation backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. This deviceK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. Descendant · cites it directly · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
  5. Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  6. Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  7. Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  8. Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled

Showing 5 of 393 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12003: 12004: 22005: 32006: 42007: 32008: 62009: 42010: 22011: 92012: 52013: 162014: 192015: 112016: 102017: 222018: 172019: 302020: 302021: 282022: 262023: 322024: 362025: 342026: 40
1999high 40 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 393 · See all
  • K990156Multitak SS ButtonsBonutti Research · 1999 · cites it directly336descendants
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · 2 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
0 (this device)K973015Multitak SS Suture SystemBonutti Research1997—
+1K990156Multitak SS ButtonsBonutti Research1999—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200310
200420
200530
200640
200730
200860
200940
201020
201190
201250
2013160
2014190
2015110
2016100
2017220
2018170
2019300
2020300
2021280
2022260
2023320
2024360
2025340
2026400
FIG. 1 — Lineage of K973015, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K934183Bonutti Anchor
Summary page 1
…ssification Name 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener . Predicate Devices . Multitak SS Suture System, manufactured by Bonutti Research, K934183. . Multitak SS Suture System, manufactured by Bonutti Research, K964532. . Statak Soft Tissue Attachment Device, manufactured b…
Apogee Medical Products, Inc.1996—
*K964532Multitak SS Suture System
Summary page 1
…ion Fastener . Predicate Devices . Multitak SS Suture System, manufactured by Bonutti Research, K934183. . Multitak SS Suture System, manufactured by Bonutti Research, K964532. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared A…
Bonutti Research1997—
*K926384Statak & Mini-Statak Soft Tissue Attachment Device
Summary page 1
…onutti Research, K934183. . Multitak SS Suture System, manufactured by Bonutti Research, K964532. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996. 10 BONUTTI RESEARCH, nc 1383 evergreen avenueg…
Zimmer, Inc.1993—
*K962397Statak Soft Tissue Attachment Device
Summary page 1
…S Suture System, manufactured by Bonutti Research, K964532. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996. 10 BONUTTI RESEARCH, nc 1383 evergreen avenueg, effingham, illinoi . Device Descript…
Zimmer, Inc.1996—

Also cleared against K934183: 2 other devices →

What descends from it? (393)

See all 393

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

NumberDeviceApplicantDecidedDescendants
K990156Multitak SS ButtonsBonutti Research1999336
K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.20086
K993115Multitak SSBonutti Research, Inc.19994
K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine20103

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 7 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K990156 (Bonutti Research, 1999) has gone furthest, with 336 descendants of its own.
  • 2 other devices also cite its predicate K934183.

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

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
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

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Shoulder Bankart lesion repairs S.L.A.P. lesion repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repairs Biceps tenodesis Knee Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar tendon repair VMO…

Read the full statement (105 words)

The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications:

Shoulder

Bankart lesion repairs

S.L.A.P. lesion repairs

Acromio-clavicular repairs

Capsular shift/capsulolabral reconstruction

Deltoid repair

Rotator cuff tear repairs

Biceps tenodesis

Knee

Extra-capsular repairs:

Medial collateral ligament

Lateral collateral ligament

Posterior oblique ligament

Iliotibial band tenodesis

Patellar tendon repair

VMO advancement

Joint capsule closure

Foot and Ankle

Medial/lateral repairs, reconstructions

Achilles tendon repairs

Midfoot and forefoot repairs

Hallux valgus reconstruction

Hand/Wrist

Collateral ligament repair (Gamekeeper's Thumb)

Scapholunate ligament reconstruction

Tendon transfers in phalanx

Volar plate reconstruction

Elbow

Ulnar or radial collateral ligament reconstructions

Tennis elbow repair

Biceps tendon reattachment

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

Also cleared against K934183

2 other devices cite the same predicate.

  • K971144Multitak SS Suture SystemBonutti Research · 1997
  • K964324Multitak SS Suture SystemBonutti Research · 1997

More from Bonutti Research

5 FDA decisions under this applicant name. See the company

  • K990156Multitak SS ButtonsBonutti Research · 1999
  • K971144Multitak SS Suture SystemBonutti Research · 1997
  • K964532Multitak SS Suture SystemBonutti Research · 1997
  • K964324Multitak SS Suture SystemBonutti Research · 1997

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K973015 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973015: Multitak SS Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973015

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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