510(k) Report

510(k) · Cleared

Cleared

Resofix Bioabsorbable Expansion Bolt

K043411510(k) TraditionalCleared Feb 17, 200569-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

Resofix, Inc. · HTN Washer, Bolt Nut

Cleared on Feb 17, 2005 after a 69-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.

Decided
Feb 17, 2005
Review
69 days
Class
Class II
Product code
HTN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2013: 2 descendants cleared2009: 2 descendants cleared2011: 1 descendant cleared2021: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2017: 2 descendants clearedReference device: K983592 · Sulzer Orthopedics Sysorb Interference Screws · Sulzer Orthopedics, Inc. · 199920052010201520202025
  1. This deviceK043411 Resofix Bioabsorbable Expansion BoltResofix, Inc. · 2005
  2. Descendant · cites it directly · 14 of its ownK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
  3. Descendant · 2 generations on · 13 of its ownK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
  4. Descendant · 3 generations on · 6 of its ownK092483 Bard Permafix Fixation System, Model 0113012, 0113014, 0113016…C.R. Bard, Inc. · 2009
  5. Descendant · 3 generations on · 4 of its ownK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
  6. Descendant · 4 generations on · 3 of its ownK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006: 12009: 22011: 12013: 22014: 12015: 12016: 12017: 22019: 22021: 2
2006high 2 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all
  • K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006 · cites it directly14descendants
  • K082396Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…C.R. Bard, Inc. · 2009 · 2 generations on13descendants
  • K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc. · 2009 · 3 generations on6descendants
  • K132134Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013 · 3 generations on4descendants
  • K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…C.R. Bard, Inc. · 2015 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043411Resofix Bioabsorbable Expansion BoltResofix, Inc.2005—
+1K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC2006—
+2K082396Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084…C.R. Bard, Inc.2009—
+3K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc.2009—
+3K132134Optifix Absorbable Fixation SystemC.R. Bard, Inc.2013—
+4K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners…C.R. Bard, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200920
201110
201320
201410
201510
201610
201720
201920
202120
FIG. 1 — Lineage of K043411, 2005–2021Source: 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), 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 HTN? 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 HTN device

  1. #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 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
*—Arthrex Bio-Interference Screw
Named without a submission number
—
†K983592Sulzer Orthopedics Sysorb Interference ScrewsSulzer Orthopedics, Inc.1999—

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC200614

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, K060494 (Medchannel, LLC, 2006) has gone furthest, with 14 descendants of its own.

How does its category compare?

All HTN devices

HTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTN

4in 2025

2007: 12008: 22009: 32011: 42013: 32014: 82015: 22016: 12017: 62018: 22019: 52020: 32021: 22022: 52023: 22024: 62025: 42026 (partial year): 2
2007high 8 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTN

75in 2025

2009: 86 days median2011: 130 days median2013: 105 days median2014: 98 days median2017: 88 days median2019: 116 days median2020: 87 days median2022: 86 days median2024: 90 days median2025: 75 days median
2007high 130 (2011) · low 75 (2025)2026

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

Recalls per year · HTN

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · HTN

190in 2025

2007: 142008: 112009: 222010: 172011: 122012: 692013: 452014: 332015: 352016: 432017: 302018: 482019: 532020: 812021: 1492022: 852023: 1082024: 2692025: 190
2007high 269 (2024) · low 11 (2008)2025

MAUDE reports naming product code HTN, 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
20071—014
20082—011
2009386022
20100—017
20114130012
20120—069
20133105145
2014898033
20152—035
20161—043
2017688030
20182—048
20195116153
2020387081
20212—0149
2022586085
20232—0108
20246900269
20254750190
20262—0—

What is it indicated for?

The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

Indications for use as stated in the FDA summary.

Recent decisions in HTN

The HTN category page

  • K253115Lars AcjMovmedix S.A.S. · 2026
  • K252081SportLinc Syndesmosis DeviceLincotek Medical · 2026
  • K253727Syndesmosis TightRope PROArthrex, Inc. · 2025
  • K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation) · 2025
  • K251134RipCordTriMed, Inc. · 2025

https://510kreport.com/device/K043411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043411: Resofix Bioabsorbable Expansion Bolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043411

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026