510(k) Report

510(k) · Cleared

Cleared

Smith and Nephew Titanium Interference Screws

K040331510(k) TraditionalCleared Apr 14, 200463-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

Smith & Nephew, Inc. · HWC Screw, Fixation, Bone

Cleared on Apr 14, 2004 as substantially equivalent to K895711 (Acufex Microsurgical, Inc., 1990) and 3 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1990. 10 later devices descend from it.

Decided
Apr 14, 2004
Review
63 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K895711 (1990). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor2018: 1 descendant cleared2009: 2 descendants cleared2021: 2 descendants cleared2020: 2 descendants cleared2011: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant clearedK895711 · Acufex Interference Screw, Sterile · Acufex Microsurgical, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K895711 · Acufex Interference Screw, Sterile · Acufex Microsurgical, Inc. · 19900
  1. Root · 1 generation backK895711 Acufex Interference Screw, SterileAcufex Microsurgical, Inc. · 1990
  2. This deviceK040331 Smith and Nephew Titanium Interference ScrewsSmith & Nephew, Inc. · 2004
  3. Descendant · cites it directly · 7 of its ownK083619 Parcus Tintanium Interference Screw, Models: 10001-10012…Parcus Medical, LLC · 2009
  4. Descendant · 2 generations on · 4 of its ownK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
  5. Descendant · cites it directly · 2 of its ownK180573 Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018
  6. Descendant · 3 generations on · 1 of its ownK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
  7. Descendant · 3 generations on · 1 of its ownK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 22011: 12013: 12017: 12018: 12020: 22021: 2
2009high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC · 2009 · cites it directly7descendants
  • K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009 · 2 generations on4descendants
  • K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018 · cites it directly2descendants
  • K170877Parcus SLiK Fix ScrewParcus Medical · 2017 · 3 generations on1descendant
  • K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895711Acufex Interference Screw, SterileAcufex Microsurgical, Inc.1990—
0 (this device)K040331Smith and Nephew Titanium Interference ScrewsSmith & Nephew, Inc.2004—
+1K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016…Parcus Medical, LLC2009—
+2K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC2009—
+1K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC2018—
+3K170877Parcus SLiK Fix ScrewParcus Medical2017—
+3K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201110
201310
201710
201810
202020
202120
FIG. 1 — Lineage of K040331, 1990–2021Source: 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 22.3 · 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? (4)

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
*K895711Acufex Interference Screw, Sterile
Summary page 1
…e Screws are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screw…
Acufex Microsurgical, Inc.1990—
*K900132Acufex Sterile Cannulated Interference Screw;
Summary page 1
…substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screws.…
Acufex Microsurgical, Inc.1990—
*K932027Oregon Fixation System Interference Screw
Summary page 1
…Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screws.…
Acu Med, Inc.1994—
*K921481Interference-Cannu-Flex/Silk Screws-Screw DR/G Wir
Summary page 1
…to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screws. FC…
Acufex Microsurgical, Inc.19931

Also cleared against K895711: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC20097
K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182

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 4 ancestors has a recall of any class.
  • Of its descendants, K083619 (Parcus Medical, LLC, 2009) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K895711.

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 Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Indications for use as stated in the FDA summary.

Also cleared against K895711

1 other device cites the same predicate.

  • K970829Phusis Absorbable Interference ScrewTornier · 1998

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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https://510kreport.com/device/K040331 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040331: Smith and Nephew Titanium Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040331

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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