510(k) · Cleared

Cleared

Lactosorb Screw Anchor

K003273510(k) TraditionalCleared Jan 11, 200185-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, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 11, 2001 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided: Jan 11, 2001
Review: 85 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 0

31 later devices descend from it, 3 citing it directly.

This deviceK003273 Lactosorb Screw AnchorBiomet, Inc. · 2001
Descendant · cites it directly · 30 of its ownK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
Descendant · 2 generations on · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
Descendant · 3 generations on · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
Descendant · 2 generations on · 8 of its ownK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
Descendant · 4 generations on · 7 of its ownK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2001high 6 (2011) · low 0 (2002)2026

Most influential descendants

Showing 5 of 31 · See all

K012872Resorbable Screw AnchorArthrotek, Inc. · 2001 · cites it directly30descendants
K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · 2 generations on26descendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · 3 generations on9descendants
K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004 · 2 generations on8descendants
K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003273	Lactosorb Screw Anchor	Biomet, Inc.	2001	—
+1	K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	—
+2	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+3	K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	1
+2	K033355	Lactoscrew Screw Anchor	Biomet Orthopedics, Inc.	2004	—
+4	K110230	Rog Knotless Suture Anchor	Rog Sports Medicine, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	3	0
2006	2	0
2007	2	0
2008	1	0
2011	6	0
2013	4	0
2014	2	0
2015	1	0
2016	2	0
2018	1	0
2020	4	0
2023	1	0

FIG. 1 — Lineage of K003273, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	30
K061801	2.8 & 3.5MM Lactoscrew Suture Anchors	Arthrotek, Inc.	2006	7
K032072	Lactosorb L15 Screw Anchor with Lactocarbonate Suture	Arthrotek, Inc.	2003	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?

Of its descendants, K012872 (Arthrotek, Inc., 2001) has gone furthest, with 30 descendants of its own.

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	—

https://510kreport.com/device/K003273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003273: Lactosorb Screw Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003273

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026