510(k) Report

510(k) · Cleared

Cleared

Statak & Mini-Statak Soft Tissue Attachment Device

K926384510(k) TraditionalCleared Nov 16, 1993329-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

Zimmer, Inc. · JDR Staple, Fixation, Bone

Cleared on Nov 16, 1993 after a 329-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 539 later devices descend from it.

Decided
Nov 16, 1993
Review
329 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

539 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 1997: 5 descendants cleared2007: 6 descendants cleared1996: 1 descendant cleared1998: 5 descendants cleared2020: 33 descendants cleared2009: 11 descendants cleared2010: 7 descendants cleared2002: 4 descendants cleared2003: 2 descendants cleared1999: 5 descendants cleared2008: 9 descendants cleared2004: 4 descendants cleared2006: 7 descendants cleared2017: 26 descendants cleared2011: 14 descendants cleared2013: 18 descendants cleared2014: 24 descendants cleared2001: 1 descendant cleared2005: 4 descendants cleared2012: 8 descendants cleared2019: 34 descendants cleared2015: 14 descendants cleared2016: 12 descendants cleared2023: 45 descendants cleared2018: 19 descendants cleared2024: 50 descendants cleared2025: 55 descendants cleared2021: 31 descendants cleared2022: 33 descendants cleared2026: 52 descendants cleared1990200020102020
  1. This deviceK926384 Statak & Mini-Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1993
  2. Descendant · cites it directly · 531 of its ownK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. Descendant · cites it directly · 393 of its ownK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. Descendant · 2 generations on · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
  5. Descendant · 3 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  6. Descendant · 4 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005

Showing 5 of 539 descendants. See all descendants

Descendants cleared per year

1996: 11997: 51998: 51999: 52001: 12002: 42003: 22004: 42005: 42006: 72007: 62008: 92009: 112010: 72011: 142012: 82013: 182014: 242015: 142016: 122017: 262018: 192019: 342020: 332021: 312022: 332023: 452024: 502025: 552026: 52
1996high 55 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 539 · See all
  • K962397Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996 · cites it directly531descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926384Statak & Mini-Statak Soft Tissue Attachment DeviceZimmer, Inc.1993—
+1K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
+1K973015Multitak SS Suture SystemBonutti Research1997—
+2K990156Multitak SS ButtonsBonutti Research1999—
+3K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199750
199850
199950
200110
200240
200320
200440
200540
200670
200760
200890
2009110
201070
2011140
201280
2013180
2014240
2015140
2016120
2017260
2018190
2019340
2020330
2021310
2022330
2023450
2024500
2025550
2026520
FIG. 1 — Lineage of K926384, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (539)

See all 539

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

NumberDeviceApplicantDecidedDescendants
K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996531
K973015Multitak SS Suture SystemBonutti Research1997393
K963369Bio-AnchorLinvatec Corp.199781
K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077
K963932Preloaded Soft Tissue AnchorLinvatec Corp.19971
K980595Depuy Orthotech Catera Suture AnchorDePuy Orthopaedics, Inc.19980
K980103Acumed Suture AnchorAcu Med, Inc.19980
K963502Csco Forehead Fixation SystemHowmedica Corp.19970
K971144Multitak SS Suture SystemBonutti Research19970

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, K962397 (Zimmer, Inc., 1996) has gone furthest, with 531 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

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Recent decisions in JDR

The JDR category page

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  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
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https://510kreport.com/device/K926384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926384: Statak & Mini-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/K926384

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026