510(k) Report

510(k) · Cleared

Recalled · 2003

M. Kurosaka Interference Fixation Screw

K933738510(k) TraditionalCleared Feb 23, 1994204-day reviewClass II21 CFR 888.3040Recalls 2

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 Feb 23, 1994 after a 204-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it. It has been recalled 2 times.

Decided
Feb 23, 1994
Review
204 days
Class
Class II
Product code
HWC
Recalls
2
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 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 cleared1990200020102020
  1. This deviceK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994
  2. Descendant · cites it directly · 21 of its ownK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
  3. Descendant · 2 generations on · 20 of its ownK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
  4. Descendant · 2 generations on · 18 of its ownK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
  5. Descendant · 2 generations on · 17 of its ownK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
  6. Descendant · 2 generations on · 16 of its ownK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1996: 11998: 41999: 12004: 12005: 22007: 22009: 12010: 22012: 32017: 22018: 22022: 1
1996high 4 (1998) · low 0 (1997)2026

Most influential descendants

Showing 5 of 22 · See all
  • K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996 · cites it directly21descendants
  • K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998 · 2 generations on20descendants
  • K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference…Depuy, Inc. · 1998 · 2 generations on18descendants
  • K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference ScrewDePuy Orthopaedics, Inc. · 1998 · 2 generations on17descendants
  • K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd. · 1999 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933738M. Kurosaka Interference Fixation ScrewDepuy, Inc.1994—
+1K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc.1996—
+2K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc.1998—
+2K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable…Depuy, Inc.1998—
+2K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable…DePuy Orthopaedics, Inc.19984
+2K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…Bionx Implants, Ltd.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199840
199910
200410
200520
200720
200910
201020
201230
201720
201820
202210
FIG. 1 — Lineage of K933738, 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), 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
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  3. #3 Held for the reportin the report
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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? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc.199621

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 28, 2003Not classifiedZ-0697-03OtherMislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm
Feb 28, 2003Not classifiedZ-0696-03OtherMislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K955733 (Depuy, Inc., 1996) has gone furthest, with 21 descendants of its own.

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—

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https://510kreport.com/device/K933738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933738: M. Kurosaka Interference Fixation Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933738

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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