← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K963288

# LM BONE ANCHOR (K963288)

_Li Medical Technologies, Inc. · MBI · Nov 13, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963288

## Device Facts

- **Applicant:** Li Medical Technologies, Inc.
- **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md)
- **Decision Date:** Nov 13, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

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.

## Device Story

Bone anchor system for soft tissue-to-bone attachment; used in bladder neck suspension procedures. Device consists of crown and center pin for suture passage. Implanted into pubic bone by surgeons. Provides mechanical fixation for sutures; facilitates tissue stabilization. Benefits patients by restoring bladder neck support to treat urinary incontinence.

## Clinical Evidence

Bench testing only. Pre-clinical cadaver specimen study compared mean pullout strength of LM Anchor Products to Mitek anchors, showing substantial equivalence.

## Technological Characteristics

Materials: 316L surgical grade stainless steel or 6Al-4V ELI titanium. Design: Cylindrical anchor with crown and center pin for suture passage. Fixation mechanism: Cantilevered beams.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- Mitek Surgical Products GII QuickAnchor ([K904436](/device/K904436.md))
- Li Medical Bone Anchor ([K951233](/device/K951233.md))
- Li Medical Bone Anchor ([K951472](/device/K951472.md))
- Li Medical Bone Anchor ([K953764](/device/K953764.md))
- Li Medical Bone Anchor ([K960448](/device/K960448.md))
- Li Medical Bone Anchor ([K960439](/device/K960439.md))
- Li Medical Bone Anchor ([K960825](/device/K960825.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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NOV 13 1996
K963288

# 510(K) SUMMARY

|  Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484, 203-944-2800  |
| --- | --- |
|  Contact: | Rhodemann Li, Vice President  |
|  Date: | October 30, 1996  |
|  Classification Name: | Staple, Fixation, Bone  |
|  Common Name: | Bone anchor  |
|  Proprietary Name: | LM Anchor Products or other proprietary names  |
|  Predicate Devices: | Mitek Surgical Products GII QuickAnchor (K904436)
Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825)  |
|  Device Description: | Made from surgical grade stainless steel (316L) or titanium (6Al-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.  |
|  Intended Use:
(UltraFix RC, UltraFix Mini, UltraFix) | 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.  |
|  Technical Comparison: | The LM Anchor Products are similar to the Mitek anchors in its cylindrical shape; however, the bony purchase is accomplished by the LM Anchor Products through cantilevered beams versus nitinol arcs with the Mitek anchors.  |
|  Performance Data: | Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors.  |

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963288](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K963288)

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