510(k) Report

510(k) · Cleared

Cleared

Biocryl Rapide Interference Screw

K032717510(k) TraditionalCleared Mar 31, 2004211-day reviewClass II21 CFR 888.3040

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

Mitek Worldwide · HWC Screw, Fixation, Bone

Cleared on Mar 31, 2004 as substantially equivalent to K013572 (Mitek Products, 2002) after a 211-day review. Its family tree reaches back 4 generations to 1997. 107 later devices descend from it.

Decided
Mar 31, 2004
Review
211 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K971358 (1997). 6 ancestors in all. 107 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2007: 3 descendants cleared2013: 7 descendants cleared2012: 4 descendants cleared2006: 1 descendant cleared2011: 6 descendants cleared2008: 1 descendant cleared2016: 4 descendants cleared2010: 3 descendants cleared2018: 7 descendants cleared2019: 8 descendants cleared2009: 1 descendant cleared2017: 4 descendants cleared2025: 10 descendants cleared2024: 7 descendants cleared2014: 4 descendants cleared2022: 5 descendants cleared2021: 7 descendants cleared2026: 9 descendants cleared2020: 5 descendants cleared2023: 11 descendants clearedK971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 1997K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K013572 · Mitek Biocryl Interference Screws · Mitek Products · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 24 descendants3 generations forward: 26 descendants4 generations forward: 22 descendants5 generations forward: 9 descendants6 generations forward: 15 descendants7 generations forward: 2 descendants K013572 · Mitek Biocryl Interference Screws · Mitek Products · 2002K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 19970+5
  1. Root · 4 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 3 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
  3. 2 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  4. 1 generation backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
  5. This deviceK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  6. Descendant · cites it directly · 103 of its ownK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
  7. Descendant · cites it directly · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
  8. Descendant · cites it directly · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  9. Descendant · 2 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
  10. Descendant · 3 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2006: 12007: 32008: 12009: 12010: 32011: 62012: 42013: 72014: 42016: 42017: 42018: 72019: 82020: 52021: 72022: 52023: 112024: 72025: 102026: 9
2006high 11 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 107 · See all
  • K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly103descendants
  • K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · cites it directly47descendants
  • K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly44descendants
  • K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
  • K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc.1997—
−3K990454Bio-Interference ScrewInnovasive Devices, Inc.1999—
−2K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc.1999—
−1K013572Mitek Biocryl Interference ScrewsMitek Products2002—
0 (this device)K032717Biocryl Rapide Interference ScrewMitek Worldwide2004—
+1K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006—
+1K071176Modification to: Arthrex Interference ScrewArthrex, Inc.2007—
+1K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
+2K151342Arthrex SwiveLock AnchorsArthrex, Inc.2016—
+3K171141Arthrex SwiveLock AnchorsArthrex, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200730
200810
200910
201030
201160
201240
201370
201440
201640
201740
201870
201980
202050
202170
202250
2023110
202470
2025100
202690
FIG. 1 — Lineage of K032717, 1997–2026Source: 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), 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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
*K013572Mitek Biocryl Interference Screws
Summary page 1
…ate device used to determine substantial equivalence for the Mitek's Biocryl Rapide Interference Screws is the Biocryl Interference Screws (K013572) currently marketed by Mitek Worldwide, Norwood, MA 02062. 4. DEVICE DESCRIPTION: The Mitek Biocryl Ra…
Mitek Products2002—

Also cleared against K013572: 5 other devices →

What descends from it? (107)

See all 107

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

NumberDeviceApplicantDecidedDescendants
K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103
K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747
K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company200844
K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118
K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113
K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077
K123362Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20135
K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121
K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120

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 7 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K060830 (Depuy Mitek, A Johnson & Johnson Company, 2006) has gone furthest, with 103 descendants of its own.
  • 5 other devices also cite its predicate K013572.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Mitek Biocryl Rapide Interference Screw is indicated for fixation of soft tissue

grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the

knee.

Indications for use as stated in the FDA summary.

Also cleared against K013572

5 other devices cite the same predicate.

  • K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
  • K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
  • K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
  • K050468Triabsorb Composite ScrewAdvanced Biomaterials · 2005
  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003

More from Mitek Worldwide

10 FDA decisions under this applicant name. See the company

  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003
  • K030995Minilok Quickanchor PlusMitek Worldwide · 2003
  • K031519Cufflok AnchorMitek Worldwide · 2003
  • K031406Exojet Tissue Management SystemMitek Worldwide · 2003

Recent decisions in HWC

The HWC category page

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https://510kreport.com/device/K032717 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032717: Biocryl Rapide Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032717

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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