510(k) Report

510(k) · Cleared

Recalled · 2006

Bone Anchor for Soft Tissue Attachment

K932925510(k) TraditionalCleared Apr 26, 1994315-day reviewClass II21 CFR 888.3030Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vesitec Medical, Inc. · JDR Staple, Fixation, Bone

Cleared on Apr 26, 1994 after a 315-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 129 later devices descend from it. It has been recalled 2 times.

Decided
Apr 26, 1994
Review
315 days
Class
Class II
Product code
JDR
Recalls
2
Predicates
0

129 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1997: 6 descendants cleared1996: 1 descendant cleared2002: 3 descendants cleared1998: 3 descendants cleared2003: 1 descendant cleared2001: 1 descendant cleared1999: 5 descendants cleared2004: 2 descendants cleared2006: 3 descendants cleared2010: 6 descendants cleared2013: 5 descendants cleared2012: 8 descendants cleared2009: 7 descendants cleared2008: 2 descendants cleared2018: 6 descendants cleared2011: 6 descendants cleared2014: 5 descendants cleared2019: 7 descendants cleared2017: 7 descendants cleared2023: 10 descendants cleared2026: 2 descendants cleared2020: 7 descendants cleared2021: 6 descendants cleared2016: 1 descendant cleared2015: 2 descendants cleared2022: 5 descendants cleared2024: 4 descendants cleared2025: 8 descendants cleared1990200020102020
  1. This deviceK932925 Bone Anchor for Soft Tissue AttachmentVesitec Medical, Inc. · 1994
  2. Descendant · cites it directly · 81 of its ownK963369 Bio-AnchorLinvatec Corp. · 1997
  3. Descendant · 2 generations on · 80 of its ownK983186 Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998
  4. Descendant · 2 generations on · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
  5. Descendant · 2 generations on · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  6. Descendant · 3 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

1996: 11997: 61998: 31999: 52001: 12002: 32003: 12004: 22006: 32008: 22009: 72010: 62011: 62012: 82013: 52014: 52015: 22016: 12017: 72018: 62019: 72020: 72021: 62022: 52023: 102024: 42025: 82026: 2
1996high 10 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 129 · See all
  • K963369Bio-AnchorLinvatec Corp. · 1997 · cites it directly81descendants
  • K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998 · 2 generations on80descendants
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
  • K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 3 generations on76descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932925Bone Anchor for Soft Tissue AttachmentVesitec Medical, Inc.1994—
+1K963369Bio-AnchorLinvatec Corp.1997—
+2K983186Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp.1998—
+2K020056Duet Suture AnchorBionx Implants, Ltd.2002—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.2003—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models…Linvatec Biomaterials, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199760
199830
199950
200110
200230
200310
200420
200630
200820
200970
201060
201160
201280
201350
201450
201520
201610
201770
201860
201970
202070
202160
202250
2023100
202440
202580
202620
FIG. 1 — Lineage of K932925, 1994–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K963369Bio-AnchorLinvatec Corp.199781
K962372Urotac Bone Anchor InserterInfluence, Inc.199644
K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc.199740
K972622Straight-in Bone Screw Fixation SystemInfluence, Inc.199714
K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc.19971

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 2, 2006Not classifiedZ-1309-06OtherThe packages are labeled sterile, but the product was not sterilized.
Jun 2, 2006Not classifiedZ-1308-06OtherThe packages are labeled sterile, but the product was not sterilized.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963369 (Linvatec Corp., 1997) has gone furthest, with 81 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—

More from Vesitec Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K931182Vesitec Drill GuideVesitec Medical, Inc. · 1993
  • K931181Vesitec Suture PasserVesitec Medical, Inc. · 1993

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K932925 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932925: Bone Anchor for Soft Tissue Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932925

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026