510(k) · Cleared

Cleared

LMT Bone Anchor

K953764510(k) TraditionalCleared Aug 25, 199514-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

Li Medical Technologies, Inc. · JDR Staple, Fixation, Bone

Cleared on Aug 25, 1995 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 60 later devices descend from it.

Decided: Aug 25, 1995
Review: 14 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 0

60 later devices descend from it, 2 citing it directly.

This deviceK953764 LMT Bone AnchorLi Medical Technologies, Inc. · 1995
Descendant · cites it directly · 58 of its ownK963812 LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
Descendant · 3 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
Descendant · 4 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
Descendant · 5 generations on · 12 of its ownK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

1996high 8 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 60 · See all

K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996 · cites it directly58descendants
K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 2 generations on56descendants
K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 3 generations on29descendants
K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 4 generations on17descendants
K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation · 2014 · 5 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953764	LMT Bone Anchor	Li Medical Technologies, Inc.	1995	—
+1	K963812	LM Bone Anchor (Orthopedics)	Li Medical Technologies, Inc.	1996	—
+2	K091549	Conmed Linvatec Soft Tissue to Bone System	Linvatec Corp.	2009	1
+3	K111779	Y-Knot All-Suture Anchor Model HF13	Conmed Linvatec	2011	—
+4	K131035	Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM	Linvatec Corporation D/B/A Conmed Linvatec	2013	—
+5	K133224	Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2…	Conmed Corporation	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2001	1	0
2009	1	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	2	0
2015	1	0
2016	1	0
2017	7	0
2018	4	0
2019	6	0
2020	4	0
2021	2	0
2022	2	0
2023	8	0
2024	2	0
2025	8	0
2026	2	0

FIG. 1 — Lineage of K953764, 1995–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (60)

See all 60

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

Number	Device	Applicant	Decided	Descendants
K963812	LM Bone Anchor (Orthopedics)	Li Medical Technologies, Inc.	1996	58
K963288	LM Bone Anchor	Li Medical Technologies, Inc.	1996	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, K963812 (Li Medical Technologies, Inc., 1996) has gone furthest, with 58 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/K953764 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953764: LMT Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953764

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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