510(k) Report

510(k) · Cleared

Cleared

Multitak SS Suture System

K971144510(k) TraditionalCleared Jun 25, 199789-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 Jun 25, 1997 as substantially equivalent to K934183 (Apogee Medical Products, Inc., 1996) and 5 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990.

Decided
Jun 25, 1997
Review
89 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K904436 (1990). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestorK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 199619901992199419961998
Other ancestors, by generation 1 generation back: 4 other ancestors K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 19900
  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 deviceK971144 Multitak SS Suture SystemBonutti Research · 1997
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)K971144Multitak SS Suture SystemBonutti Research1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199610
FIG. 1 — Lineage of K971144, 1990–1997Source: 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 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
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What was it cleared against? (6)

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
…assification Name 21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener Predicate Devices . Multitak SS Suture System, manufactured by Bonutti Research, K934183. . GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877. . Mini QuickAnchor, manufactured by Mitek Surgica…
Apogee Medical Products, Inc.1996—
*K953877Mitek Gii Anchor
Summary page 1
…Fastener Predicate Devices . Multitak SS Suture System, manufactured by Bonutti Research, K934183. . GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877. . Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436. . Statak Soft Tissue Attachment Device…
Mitek Surgical Products, Inc.1995—
*K930892Mitek Mini Anchor, Modification
Summary page 1
…utti Research, K934183. . GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877. . Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K9623…
Mitek Surgical Products, Inc.1994—
*K904436Quickanchor (TM)
Summary page 1
…h, K934183. . GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877. . Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared…
Mitek Surgical Products, Inc.1990—
*K926384Statak & Mini-Statak Soft Tissue Attachment Device
Summary page 1
…K953877. . Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996. Device Description The anchor is tubular in sh…
Zimmer, Inc.1993—
*K962397Statak Soft Tissue Attachment Device
Summary page 1
…red by Mitek Surgical Products, Inc., K930892 and K904436. . Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996. Device Description The anchor is tubular in shape and is preassembled threaded with U…
Zimmer, Inc.1996—

Also cleared against K934183: 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 7 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 6 ancestors has a recall.
  • 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 devices are 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 Foot and Ankle - Medial/lateral repairs, reconstructions - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction Elbow - Ulnar or…

Read the full statement (125 words)

The devices are 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

Foot and Ankle

- Medial/lateral repairs, reconstructions

- Achilles tendon repairs

- Midfoot and forefoot repairs

- Hallux Valgus reconstruction

Elbow

- 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

- Iliotibial band tenodesis

- Patellar tendon repair

- VMO advancement

- Joint capsule closure

Hand/Wrist

- Collateral ligament repair (Gamekeeper's Thumb)

- Scapholunate ligament reconstruction

- Tendon transfers in phalanx

- Volar plate reconstruction

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.

  • K973015Multitak 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
  • K973015Multitak 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/K971144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971144: 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/K971144

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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