510(k) Report

510(k) · Cleared

Cleared

Multitak Splinter 3.0 MM Resorbable Anchor

K012465510(k) TraditionalCleared Oct 29, 200189-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 Oct 29, 2001 after an 89-day review. The FDA summary names its predicate without a number. 310 later devices descend from it.

Decided
Oct 29, 2001
Review
89 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

310 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 5 descendants cleared2005: 2 descendants cleared2013: 7 descendants cleared2018: 15 descendants cleared2019: 26 descendants cleared2017: 15 descendants cleared2011: 5 descendants cleared2020: 22 descendants cleared2024: 35 descendants cleared2025: 30 descendants cleared2015: 9 descendants cleared2014: 18 descendants cleared2021: 22 descendants cleared2006: 1 descendant cleared2012: 3 descendants cleared2022: 22 descendants cleared2026: 34 descendants cleared2009: 4 descendants cleared2016: 6 descendants cleared2023: 26 descendants cleared2007: 2 descendants cleared200020052010201520202025
  1. This deviceK012465 Multitak Splinter 3.0 MM Resorbable AnchorBonutti Research, Inc. · 2001
  2. Descendant · cites it directly · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  3. Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  4. Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  5. Descendant · 3 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  6. Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011

Showing 5 of 310 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 22008: 52009: 42011: 52012: 32013: 72014: 182015: 92016: 62017: 152018: 152019: 262020: 222021: 222022: 222023: 262024: 352025: 302026: 34
2004high 35 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 310 · See all
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · cites it directly309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 3 generations on94descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012465Multitak Splinter 3.0 MM Resorbable AnchorBonutti Research, Inc.2001—
+1K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+3K083070Toggleloc SystemBiomet Sports Medicine20086
+3K112437Arthrex Fracture SystemArthrex, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200720
200850
200940
201150
201230
201370
2014180
201590
201660
2017150
2018150
2019260
2020220
2021220
2022220
2023260
2024350
2025300
2026340
FIG. 1 — Lineage of K012465, 2001–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Mitek 3.5 mm Panalok Wedge Absorbable Suture System
Named without a submission number
—
*—Multitak suture anchors
Named without a submission number
—

What descends from it? (310)

See all 310

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

NumberDeviceApplicantDecidedDescendants
K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309

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?

  • Of its descendants, K033717 (Bonutti Research, Inc., 2004) has gone furthest, with 309 descendants of its own.

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?

The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures. The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart…

Read the full statement (122 words)

The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.

The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

Shoulder:

Bankart lesion repairs

Acromio-clavicular repairs

Deltoid repairs

Rotator cuff tear repairs

Biceps tenodesis

Elbow:

Ulnar or radial collateral ligament reconstruction

Knee:

Extra-capsular repairs

Medial collateral ligament repair

Lateral collateral ligament repair

Posterior oblique ligament repair

Iliotibial band tenodesis

Patellar tendon repair

VMO advancement

Joint capsule closure

Foot/Ankle:

Medial/Lateral repairs/reconstructions

Achilles tendon repairs

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

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

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The MAI category page

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https://510kreport.com/device/K012465 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012465: Multitak Splinter 3.0 MM Resorbable Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012465

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026