510(k) Report

510(k) · Cleared

Cleared

Hyloc Interference Screw (Cannulated)/(Non-Cannulated)

K955733510(k) TraditionalCleared Nov 18, 1996336-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

Depuy, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 18, 1996 as substantially equivalent to K933719 (Linvatec Corp., 1994) and 2 other predicates after a 336-day review. Its family tree reaches back 1 generation to 1994. 21 later devices descend from it.

Decided
Nov 18, 1996
Review
336 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K933738 (1994). 3 ancestors in all. 21 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1999: 1 descendant cleared1998: 4 descendants cleared2004: 1 descendant cleared2005: 2 descendants cleared2010: 2 descendants cleared2007: 2 descendants cleared2012: 3 descendants cleared2009: 1 descendant cleared2022: 1 descendant cleared2018: 2 descendants cleared2017: 2 descendants clearedK933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalled0+5
  1. Root · 1 generation backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
  2. This deviceK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
  3. Descendant · cites it directly · 20 of its ownK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
  4. Descendant · cites it directly · 18 of its ownK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
  5. Descendant · cites it directly · 17 of its ownK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
  6. Descendant · cites it directly · 16 of its ownK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
  7. Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998: 41999: 12004: 12005: 22007: 22009: 12010: 22012: 32017: 22018: 22022: 1
1998high 4 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998 · cites it directly20descendants
  • K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference…Depuy, Inc. · 1998 · cites it directly18descendants
  • K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference ScrewDePuy Orthopaedics, Inc. · 1998 · cites it directly17descendants
  • K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd. · 1999 · cites it directly16descendants
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933738M. Kurosaka Interference Fixation ScrewDepuy, Inc.19942
0 (this device)K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc.1996—
+1K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc.1998—
+1K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable…Depuy, Inc.1998—
+1K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable…DePuy Orthopaedics, Inc.19984
+1K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…Bionx Implants, Ltd.1999—
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…Linvatec Biomaterials, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199840
199910
200410
200520
200720
200910
201020
201230
201720
201820
202210
FIG. 1 — Lineage of K955733, 1994–2022Source: 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 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? (3)

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
*K933719Bioscrew Absorbable Interference Screw
Summary page 1
…SSIFICATION: Smooth or threaded bone fixation fastener; 888.3040 DEVICE PRODUCT CODE: 87 HWC SUBSTANTIALLY EQUIVALENT DEVICES: ) BioScrew® Fixation System (Linvatec) - K933719 ® M. Kurosaka Interference Screw (DePuy) - K933798 ® Biologically Quiet Interference Screw (Instrument Makar) - K943249 DEVICE D…
Linvatec Corp.1994—
*K933738M. Kurosaka Interference Fixation Screw
Our OCR of the scanned summary read K933798, FDA’s number for NU-Prep Gel (Cadwell Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “M. Kurosaka Interference Screw (DePuy)”.
Depuy, Inc.19942
*K943249Bioabsorbable Interference Screw
Summary page 1
…EVICES: ) BioScrew® Fixation System (Linvatec) - K933719 ® M. Kurosaka Interference Screw (DePuy) - K933798 ® Biologically Quiet Interference Screw (Instrument Makar) - K943249 DEVICE DESCRIPTION AND INTENDED USE: The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePu…
Instrument Makar, Inc.1995—

Also cleared against K933719: 5 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc.199820
K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference…Depuy, Inc.199818
K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference ScrewDePuy Orthopaedics, Inc.199817
K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd.199916

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K980440 (Depuy, Inc., 1998) has gone furthest, with 20 descendants of its own.
  • 5 other devices also cite its predicate K933719.

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 Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation.

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

Also cleared against K933719

5 other devices cite the same predicate.

  • K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T…Linvatec Biomaterials, Inc. · 2004
  • K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030Bionx Implants, Ltd. · 1999
  • K970829Phusis Absorbable Interference ScrewTornier · 1998
  • K980457Endo Absorbable Interference ScrewEndo Surgical Concepts, Inc. · 1998

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

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  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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https://510kreport.com/device/K955733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955733: Hyloc Interference Screw (Cannulated)/(Non-Cannulated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955733

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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