510(k) Report

510(k) · Cleared

Cleared

Multitak SS

K993115510(k) TraditionalCleared Dec 17, 199988-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

Bonutti Research, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Dec 17, 1999 as substantially equivalent to K973015 (Bonutti Research, 1997) after an 88-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.

Decided
Dec 17, 1999
Review
88 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K904436 (1990). 8 ancestors in all. 4 later devices descend from it, 1 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 ancestor2001: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants clearedReference device: K934183 · Bonutti Anchor · Apogee Medical Products, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K973015 · Multitak SS Suture System · Bonutti Research · 19971990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K973015 · Multitak SS Suture System · Bonutti Research · 1997K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 19900
  1. Root · 3 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 2 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. 1 generation backK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. This deviceK993115 Multitak SSBonutti Research, Inc. · 1999
  5. Descendant · cites it directly · 3 of its ownK011985 Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001
  6. Descendant · 2 generations on · 1 of its ownK042038 MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004
  7. Descendant · 2 generations on · 0 of its ownK061498 Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · Recalled
  8. Descendant · 3 generations on · 0 of its ownK053339 Allofix AnchorMusculoskeletal Transplant Foundation · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001 · cites it directly3descendants
  • K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004 · 2 generations on1descendant
  • K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · 2 generations on0descendants
  • K053339Allofix AnchorMusculoskeletal Transplant Foundation · 2006 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−2K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
−1K973015Multitak SS Suture SystemBonutti Research1997—
0 (this device)K993115Multitak SSBonutti Research, Inc.1999—
+1K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.2001—
+2K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation2004—
+2K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation20061
+3K053339Allofix AnchorMusculoskeletal Transplant Foundation2006—

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
200110
200410
200620
FIG. 1 — Lineage of K993115, 1990–2006Source: 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 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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (1)

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
*K973015Multitak SS Suture System
Summary page 2
…rs in phalanx Volar plate reconstruction Predicate Device: The Multitak SS™ bone anchors are similar in intended use and design to Multitak SS™ titanium suture anchors (K973015.) The bone anchors method of insertion with disposable or reusable introduction devices is similar in design and materials to cur…
Bonutti Research1997—
†K934183Bonutti AnchorApogee Medical Products, Inc.1996—

Also cleared against K973015: 4 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013

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 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K011985 (Smith & Nephew, Inc., 2001) has gone furthest, with 3 descendants of its own.
  • 4 other devices also cite its predicate K973015.

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.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
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

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

Multitak SS™ bone anchors are intended for use as a load bearing or non-load bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures. Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart lesion repairs S.L.A.P. lesions repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repairs Rotator cuff…

Read the full statement (136 words)

Multitak SS™ bone anchors are intended for use as a load bearing or non-load bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures.

Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

Shoulder:

Bankart lesion repairs

S.L.A.P. lesions repairs

Acromio-clavicular repairs

Capsular shift/capsulolabral reconstruction

Deltoid repairs

Rotator cuff tear repairs

Biceps tenodesis

Elbow:

Biceps tendon reattachment

Tennis elbow repair

Ulnar or radial collateral ligament reconstruction

Knee:

Extra-capsular repairs

Medial collateral ligament repair

Lateral collateral ligament repair

Posterior oblique ligament repair

Illiotibial band tenodesis

Patellar tendon repair

VMO advancement

Joint capsule closure

Foot/Ankle:

Medial/Lateral repairs/reconstructions

Achilles tendon repairs

Midfoot and forefoot repairs

Hallus valgus reconstruction

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 K973015

4 other devices cite the same predicate.

  • K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine · 20101 recall
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls
  • K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
  • K990156Multitak SS ButtonsBonutti Research · 1999

More from Bonutti Research, Inc.

12 FDA decisions under this applicant name. See the company

  • K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
  • K093078Unity Ultrasonic System with Plla AnchorsBonutti Research, Inc. · 2010
  • K090175Unity Beta Plla SystemBonutti Research, Inc. · 2009
  • K082906Unity Beta Anchor SystemBonutti Research, Inc. · 2008
  • K062820Unity Alpha SystemBonutti Research, Inc. · 2007

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K993115 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993115: Multitak SS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993115

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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