LM BONE ANCHOR

K963288 · Li Medical Technologies, Inc. · MBI · Nov 13, 1996 · Orthopedic

Device Facts

• Record ID: K963288
• Device Name: LM BONE ANCHOR
• Applicant: Li Medical Technologies, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• 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.

Indications for Use

Indicated for female patients with urinary incontinence due to urethral hypermobility requiring bladder neck suspension.

Regulatory Classification

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)
• Li Medical Bone Anchor (K951233)
• Li Medical Bone Anchor (K951472)
• Li Medical Bone Anchor (K953764)
• Li Medical Bone Anchor (K960448)
• Li Medical Bone Anchor (K960439)
• Li Medical Bone Anchor (K960825)

Submission Summary (Full Text)

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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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