510(k) Report

510(k) · Cleared

Cleared

Bioscrew Xtralok, 8X35MM & 8X40MM Violet

K050497510(k) SpecialCleared Mar 25, 200525-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

Linvatec Corp. · HWC Screw, Fixation, Bone

Cleared on Mar 25, 2005 as substantially equivalent to K013131 (Linvatec Corp., 2002) after a 25-day review. Its family tree reaches back 2 generations to 1998. 76 later devices descend from it.

Decided
Mar 25, 2005
Review
25 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K973758 (1998). 76 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 6 descendants cleared2008: 1 descendant cleared2010: 3 descendants cleared2011: 3 descendants cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2013: 3 descendants cleared2019: 6 descendants cleared2026: 2 descendants cleared2020: 5 descendants cleared2016: 1 descendant cleared2014: 3 descendants cleared2015: 2 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants clearedK973758 · Bioscrew Absorbable Interference Srew · Linvatec Corp. · 1998K013131 · Bioscrew Xtralok · Linvatec Corp. · 2002 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 14 descendants4 generations forward: 15 descendants5 generations forward: 21 descendants6 generations forward: 12 descendants7 generations forward: 6 descendants K013131 · Bioscrew Xtralok · Linvatec Corp. · 2002 · recalledK973758 · Bioscrew Absorbable Interference Srew · Linvatec Corp. · 19980+5
  1. Root · 2 generations backK973758 Bioscrew Absorbable Interference SrewLinvatec Corp. · 1998
  2. 1 generation backK013131 Bioscrew XtralokLinvatec Corp. · 2002 · Recalled
  3. This deviceK050497 Bioscrew Xtralok, 8X35MM & 8X40MM VioletLinvatec Corp. · 2005
  4. Descendant · cites it directly · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
  5. Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
  6. Descendant · 2 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
  7. Descendant · 2 generations on · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
  8. Descendant · 3 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 62010: 32011: 32012: 22013: 32014: 32015: 22016: 12017: 72018: 42019: 62020: 52021: 42022: 42023: 82024: 32025: 82026: 2
2006high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 76 · See all
  • K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · cites it directly75descendants
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 2 generations on56descendants
  • K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 2 generations on29descendants
  • K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · 2 generations on25descendants
  • K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 3 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K973758Bioscrew Absorbable Interference SrewLinvatec Corp.1998—
−1K013131Bioscrew XtralokLinvatec Corp.20021
0 (this device)K050497Bioscrew Xtralok, 8X35MM & 8X40MM VioletLinvatec Corp.2005—
+1K053561Bio-Mini Revo Suture AnchorConmed Linvatec2006—
+2K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091
+2K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec2011—
+2K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec2008—
+3K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200960
201030
201130
201220
201330
201430
201520
201610
201770
201840
201960
202050
202140
202240
202380
202430
202580
202620
FIG. 1 — Lineage of K050497, 1998–2026Source: 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
*K013131Bioscrew Xtralok
Summary page 2
…005 510(k) Submission BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet 510(k) # _ _ D. Predicate/Legally Marketed Devices BioScrew® XtraLok TM 510(k)# K013131 Linvatec Corporation E. Device Description The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated,…
Linvatec Corp.20021

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675

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 1 company; a new generation was cleared every 4.3 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K053561 (Conmed Linvatec, 2006) has gone furthest, with 75 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—

What is it indicated for?

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

Indications for use as stated in the FDA summary.

More from Linvatec Corp.

93 FDA decisions under this applicant name. See the company

  • K092998Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 20091 recall
  • K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
  • K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp. · 2009
  • K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave…Linvatec Corp. · 2009

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K050497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050497: Bioscrew Xtralok, 8X35MM & 8X40MM Violet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050497

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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