510(k) · Cleared

Cleared

Innovasive Linx Tibial Ligament Fastener

K980491510(k) TraditionalCleared Apr 29, 199879-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

Innovasive Devices, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Apr 29, 1998 as substantially equivalent to K970316 (Innovasive Devices, Inc., 1997) after a 79-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Apr 29, 1998
Review: 79 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970316 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970316 Innovasive 8MM Ligament FastenerInnovasive Devices, Inc. · 1997
This deviceK980491 Innovasive Linx Tibial Ligament FastenerInnovasive Devices, Inc. · 1998
Descendant · cites it directly · 0 of its ownK983056 Innovasive Tibial FastenerInnovasive Devices, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K983056Innovasive Tibial FastenerInnovasive Devices, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970316	Innovasive 8MM Ligament Fastener	Innovasive Devices, Inc.	1997	—
0 (this device)	K980491	Innovasive Linx Tibial Ligament Fastener	Innovasive Devices, Inc.	1998	—
+1	K983056	Innovasive Tibial Fastener	Innovasive Devices, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K980491, 1997–1998Source: 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
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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
*	K970316	Innovasive 8MM Ligament Fastener Summary page 2 …rgeries. 6. COMPARISON OF CHARACTERISTICS: The Innovasive LinX Tibial Ligament Fastener utilizes the same basic design as the currently marketed 8mm Ligament Fastener (K970316). This design utilizes a central pin placed inside an outer sleeve resulting in the ultimate fixation of the device into bone. T…	Innovasive Devices, Inc.	1997	—
*	—	Soft Tissue Screw and Washer System Named without a submission number			—

Also cleared against K970316: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K983056	Innovasive Tibial Fastener	Innovasive Devices, Inc.	1998	0

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, K983056 (Innovasive Devices, Inc., 1998) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K970316.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

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/K980491 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980491: Innovasive Linx Tibial Ligament Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980491

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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