510(k) Report

510(k) · Cleared

Cleared

LM Bone Anchor

K963288510(k) TraditionalCleared Nov 13, 199684-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. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Nov 13, 1996 as substantially equivalent to K904436 (Mitek Surgical Products, Inc., 1990) and 6 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1992.

Decided
Nov 13, 1996
Review
84 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K921873 (1992). 11 ancestors in all, the oldest K904436 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1995: 3 other ancestors1990: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestorsK921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 1992K960448 · LM Anchor · Li Medical Technologies, Inc. · 199619901992199419961998
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors K960448 · LM Anchor · Li Medical Technologies, Inc. · 1996K921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 19920
  1. Root · 2 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
  2. 1 generation backK960448 LM AnchorLi Medical Technologies, Inc. · 1996
  3. This deviceK963288 LM Bone AnchorLi Medical Technologies, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921873Quickanchor, ModificationMitek Surgical Products, Inc.1992—
−1K960448LM AnchorLi Medical Technologies, Inc.1996—
0 (this device)K963288LM Bone AnchorLi Medical Technologies, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199220
199410
199530
199620
FIG. 1 — Lineage of K963288, 1992–1996Source: 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), 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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K904436Quickanchor (TM)
Summary page 1
…hodemann Li, Vice President October 30, 1996 Staple, Fixation, Bone Bone anchor LM Anchor Product: or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) L1 Medical Bon¢ Anchor (K951233), (K931472). (K953764), (K960448), (K960439), (K960823) Made from surgical gradc stainlcss stee…
Mitek Surgical Products, Inc.1990—
*K951233LMT Bone Anchor
Summary page 1
…ber 30, 1996 Staple, Fixation, Bone Bone anchor LM Anchor Product: or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) L1 Medical Bon¢ Anchor (K951233), (K931472). (K953764), (K960448), (K960439), (K960823) Made from surgical gradc stainlcss steel (316L) or titanium (6A1-4V ELI)…
Li Medical Technologies, Inc.1995—
*K951472LMT Bone Anchor
Our OCR of the scanned summary read K931472, FDA’s number for Careject Disposable Syringe and Needle (Carewell Mediproducts, Ltd.). Corrected to the only number one digit away that is an earlier device of this one’s maker, Li Medical Technologies, Inc., in this field.
Li Medical Technologies, Inc.1995—
*K953764LMT Bone Anchor
Summary page 1
…Fixation, Bone Bone anchor LM Anchor Product: or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) L1 Medical Bon¢ Anchor (K951233), (K931472). (K953764), (K960448), (K960439), (K960823) Made from surgical gradc stainlcss steel (316L) or titanium (6A1-4V ELI), the LM Anchor Produc…
Li Medical Technologies, Inc.1995—
*K960448LM Anchor
Summary page 1
…one Bone anchor LM Anchor Product: or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) L1 Medical Bon¢ Anchor (K951233), (K931472). (K953764), (K960448), (K960439), (K960823) Made from surgical gradc stainlcss steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are desi…
Li Medical Technologies, Inc.1996—
*K960439LM Bone Anchor
Summary page 1
…chor LM Anchor Product: or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) L1 Medical Bon¢ Anchor (K951233), (K931472). (K953764), (K960448), (K960439), (K960823) Made from surgical gradc stainlcss steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with…
Li Medical Technologies, Inc.1996—
*K960825LM Anchor or Other Proprietary Name
Our OCR of the scanned summary read K960823, FDA’s number for Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent (Dentsply Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “L1 Medical Bone Anchor”.
Li Medical Technologies, Inc.1996—

Also cleared against K904436: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
  • None of the 11 ancestors has a recall.
  • 4 other devices also cite its predicate K904436.

How does its category compare?

All MBI devices

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

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K904436

4 other devices cite the same predicate.

  • K971144Multitak SS Suture SystemBonutti Research · 1997
  • K964324Multitak SS Suture SystemBonutti Research · 1997
  • K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
  • K962397Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996

More from Li Medical Technologies, Inc.

17 FDA decisions under this applicant name. See the company

  • K002413Ultrasorb Suture AnchorLi Medical Technologies, Inc. · 2000
  • K993373Rotorblade Suture AnchorLi Medical Technologies, Inc. · 1999
  • K992938Rotorblade Suture AnchorLi Medical Technologies, Inc. · 1999
  • K983435RotorbladeLi Medical Technologies, Inc. · 1999
  • K981755LM AnchorLi Medical Technologies, Inc. · 1998

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K963288 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963288: LM 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/K963288

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026