510(k) · Cleared

Cleared

Biobutton

K990194510(k) TraditionalCleared Sep 17, 1999239-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 Sep 17, 1999 as substantially equivalent to K973758 (Linvatec Corp., 1998) after a 239-day review. Its family tree reaches back 1 generation to 1998. 310 later devices descend from it.

Decided: Sep 17, 1999
Review: 239 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973758 (1998). 310 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK973758 Bioscrew Absorbable Interference SrewLinvatec Corp. · 1998
This deviceK990194 BiobuttonLinvatec Corp. · 1999
Descendant · cites it directly · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
Descendant · 3 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011

Showing 5 of 310 descendants. See all descendants

Descendants cleared per year

2004high 35 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 310 · See all

K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · cites it directly309descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 3 generations on94descendants
K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants

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)	K990194	Biobutton	Linvatec Corp.	1999	—
+1	K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	2004	—
+2	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+3	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—
+3	K083070	Toggleloc System	Biomet Sports Medicine	2008	6
+3	K112437	Arthrex Fracture System	Arthrex, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	1	0
2007	2	0
2008	5	0
2009	4	0
2011	5	0
2012	3	0
2013	7	0
2014	18	0
2015	9	0
2016	6	0
2017	15	0
2018	15	0
2019	26	0
2020	22	0
2021	22	0
2022	22	0
2023	26	0
2024	35	0
2025	30	0
2026	34	0

FIG. 1 — Lineage of K990194, 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

Get a 510(k) Report

What was it cleared against? (2)

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 …ards Manufacturing Co., Inc. The BioButton is substantially equivalent in materials used to the BioScrew® Absorbable Interference Screw (Linvatec Corporation) - 510(K)# K973758. Testing has been done to prove safety and effectiveness of the device. The similarities/dissimilarities to the predicate are s…	Linvatec Corp.	1998	—
*	—	Hewson Ligament Guide and Button Named without a submission number			—

Also cleared against K973758: 9 other devices →

What descends from it? (310)

See all 310

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

Number	Device	Applicant	Decided	Descendants
K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	2004	309

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?

Its one ancestor has no recall.
Of its descendants, K033717 (Bonutti Research, Inc., 2004) has gone furthest, with 309 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 BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

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

https://510kreport.com/device/K990194 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990194: Biobutton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990194

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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