510(k) · Cleared

Recalled · 2005

Bioscrew Xtralok

K013131510(k) TraditionalCleared Jun 11, 2002265-day reviewClass II21 CFR 888.3040Recalls 1

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 Jun 11, 2002 as substantially equivalent to K973758 (Linvatec Corp., 1998) after a 265-day review. Its family tree reaches back 1 generation to 1998. 77 later devices descend from it. It has been recalled once.

Decided: Jun 11, 2002
Review: 265 days
Class: Class II
Product code: HWC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K973758 (1998). 77 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK973758 Bioscrew Absorbable Interference SrewLinvatec Corp. · 1998
This deviceK013131 Bioscrew XtralokLinvatec Corp. · 2002
Descendant · cites it directly · 76 of its ownK050497 Bioscrew Xtralok, 8X35MM & 8X40MM VioletLinvatec Corp. · 2005
Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
Descendant · 3 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
Descendant · 3 generations on · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2005high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 77 · See all

K050497Bioscrew Xtralok, 8X35MM & 8X40MM VioletLinvatec Corp. · 2005 · cites it directly76descendants
K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 3 generations on29descendants
K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · 3 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973758	Bioscrew Absorbable Interference Srew	Linvatec Corp.	1998	—
0 (this device)	K013131	Bioscrew Xtralok	Linvatec Corp.	2002	—
+1	K050497	Bioscrew Xtralok, 8X35MM & 8X40MM Violet	Linvatec Corp.	2005	—
+2	K053561	Bio-Mini Revo Suture Anchor	Conmed Linvatec	2006	—
+3	K091549	Conmed Linvatec Soft Tissue to Bone System	Linvatec Corp.	2009	1
+3	K111779	Y-Knot All-Suture Anchor Model HF13	Conmed Linvatec	2011	—
+3	K072291	Conmed Linvatec Bio Mini-Revo Suture Anchor	Conmed Linvatec	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	1	0
2009	6	0
2010	3	0
2011	3	0
2012	2	0
2013	3	0
2014	3	0
2015	2	0
2016	1	0
2017	7	0
2018	4	0
2019	6	0
2020	5	0
2021	4	0
2022	4	0
2023	8	0
2024	3	0
2025	8	0
2026	2	0

FIG. 1 — Lineage of K013131, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K973758	Bioscrew Absorbable Interference Srew Summary page 2 …ness BioScrewQ XtraLok Bioabsorbable Interference Screw 510(k) # KO13131 3/12/02 Page 2 of 2 D. Predicate/Legally Marketed Devices Linvatec BioScrewQ 51O(k)# K973758 E. Device Description The BioScrew XtralokTM is a cannulated, sterile, single-use bone screw made of an absorbable…	Linvatec Corp.	1998	—

Also cleared against K973758: 9 other devices →

What descends from it? (77)

See all 77

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

Number	Device	Applicant	Decided	Descendants
K050497	Bioscrew Xtralok, 8X35MM & 8X40MM Violet	Linvatec Corp.	2005	76

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 22, 2005	Not classified	Z-1551-05	Other	Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K050497 (Linvatec Corp., 2005) has gone furthest, with 76 descendants of its own.
9 other devices also cite its predicate K973758.

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

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The BioScrewB XtraLokTM interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013131: Bioscrew Xtralok.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013131

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026