510(k) Report

510(k) · Cleared

Cleared

LMT Bone Anchor

K951472510(k) TraditionalCleared Jul 3, 199595-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

Li Medical Technologies, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 3, 1995 after a 95-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
Jul 3, 1995
Review
95 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 2 descendants cleared2009: 1 descendant cleared2001: 1 descendant cleared2017: 7 descendants cleared2018: 4 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2019: 6 descendants cleared2026: 2 descendants cleared2022: 2 descendants cleared2016: 1 descendant cleared2020: 4 descendants cleared2014: 2 descendants cleared2015: 1 descendant cleared2025: 8 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared1995200020052010201520202025
  1. This deviceK951472 LMT Bone AnchorLi Medical Technologies, Inc. · 1995
  2. Descendant · cites it directly · 58 of its ownK963812 LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
  3. Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
  4. Descendant · 3 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
  5. 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
  6. 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

1996: 22001: 12009: 12010: 12011: 22012: 22013: 22014: 22015: 12016: 12017: 72018: 42019: 62020: 42021: 22022: 22023: 82024: 22025: 82026: 2
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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951472LMT Bone AnchorLi Medical Technologies, Inc.1995—
+1K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.1996—
+2K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.20091
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec2011—
+4K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec2013—
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2…Conmed Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
200110
200910
201010
201120
201220
201320
201420
201510
201610
201770
201840
201960
202040
202120
202220
202380
202420
202580
202620
FIG. 1 — Lineage of K951472, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

NumberDeviceApplicantDecidedDescendants
K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.199658
K963288LM Bone AnchorLi Medical Technologies, Inc.19960

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 HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—
Cite this page

510(k) Report. “K951472: LMT Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951472

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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