510(k) · Cleared

Cleared

Lactosorb Suture Anchor

K954443510(k) TraditionalCleared Jan 31, 1996128-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

Poly-Medics,Inc. · JDR Staple, Fixation, Bone

Cleared on Jan 31, 1996 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.

Decided: Jan 31, 1996
Review: 128 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 0

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

This deviceK954443 Lactosorb Suture AnchorPoly-Medics,Inc. · 1996
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 34 descendants. See all descendants

Descendants cleared per year

1996high 6 (2011) · low 0 (1998)2026

Most influential descendants

Showing 5 of 34 · 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)	K954443	Lactosorb Suture Anchor	Poly-Medics,Inc.	1996	—
+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
1996	1	0
1997	1	0
2001	1	0
2002	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 K954443, 1996–2023Source: 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 JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (34)

See all 34

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
K961578	Suture Anchor	United States Surgical, A Division of Tyco Healthc	1996	1
K021254	Lactosorb Mini Interference Screw	Biomet Orthopedics, Inc.	2002	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 JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

https://510kreport.com/device/K954443 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954443: Lactosorb Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954443

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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