510(k) · Cleared

Cleared

Lactosorb Meniscal Screw

K002020510(k) TraditionalCleared Aug 25, 200053-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Manufacturing, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Aug 25, 2000 as substantially equivalent to K982095 (Biomet, Inc., 1999) after a 53-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Aug 25, 2000
Review: 53 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982095 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK982095 Lactosorb Meniscal Repair DeviceBiomet, Inc. · 1999
This deviceK002020 Lactosorb Meniscal ScrewBiomet Manufacturing, Inc. · 2000
Descendant · cites it directly · 0 of its ownK031714 Inion Trinion Biodegradable Meniscus ScrewInion, Ltd. · 2004

Most influential descendants

Showing 1 of 1 · See all

K031714Inion Trinion Biodegradable Meniscus ScrewInion, Ltd. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982095	Lactosorb Meniscal Repair Device	Biomet, Inc.	1999	—
0 (this device)	K002020	Lactosorb Meniscal Screw	Biomet Manufacturing, Inc.	2000	—
+1	K031714	Inion Trinion Biodegradable Meniscus Screw	Inion, Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K002020, 1999–2004Source: 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 MAI? 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 MAI device

#1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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
*	K982095	Lactosorb Meniscal Repair Device Summary page 1 …patible in both soft tissue and bone tissue. Predicate Device: The LactoSorb® Meniscal Screw is substantially equivalent to the following: 1. LactoSorb® Meniscal Staple K982095 The LactoSorb® Meniscal Screw described in this notification has the same intended use and characteristics as the LactoSorb® Men…	Biomet, Inc.	1999	—

Also cleared against K982095: 1 other device →

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
K031714	Inion Trinion Biodegradable Meniscus Screw	Inion, Ltd.	2004	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, K031714 (Inion, Ltd., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K982095.

How does its category compare?

All MAI devices

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

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The LactoSorb Meniscal Screw is indicated for the repair of vertical longitudinal

full thickness tears (i.e. bucket-handle) in the red-red and red- white zones. These

devices are not to be used for memscal tears in the avascular zone of the meniscus.

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/K002020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002020: Lactosorb Meniscal Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002020

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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