LM ANCHOR

K960448 · Li Medical Technologies, Inc. · MBI · Apr 17, 1996 · Orthopedic

Device Facts

• Record ID: K960448
• Device Name: LM ANCHOR
• Applicant: Li Medical Technologies, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Shoulder (bankart repair), Hand (ulnar or lateral collateral ligament reconstruction), Wrist (scapholunate ligament reconstruction), Foot (hallux valgus reconstruction), and Ankle (midfoot reconstructions)

Device Story

LM Anchor; surgical grade 316L stainless steel bone anchor; crown and center pin design for suture passage; facilitates soft tissue-to-bone attachment. Used in orthopedic surgeries (shoulder, hand, wrist, foot, ankle). Physician-operated. Provides mechanical fixation for ligament/tendon repair. Benefits patient by securing soft tissue to bone during reconstructive procedures.

Clinical Evidence

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

Technological Characteristics

Material: 316L surgical grade stainless steel. Design: Cylindrical anchor with crown and center pin for suture passage. Fixation mechanism: Cantilevered beams. Non-powered, mechanical device.

Indications for Use

Indicated for soft tissue to bone attachment in shoulder (Bankart repair), hand (ulnar/lateral collateral ligament reconstruction), wrist (scapholunate ligament reconstruction), foot (hallux valgus reconstruction), and ankle (midfoot reconstruction) procedures.

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 Mini Anchor (K921873 and K930892)
• Li Medical Bone Anchor (K951233)

Submission Summary (Full Text)

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Li Medical Technologies Inc.
4 Armstrong Road
Shelton, Connecticut 06484
203-944-2800
K96 0448

APR 17 1996

Li Medical

# 510(K) SUMMARY

Device Sponsor: Li Medical, 4 Armstrong Road, Shelton, CT 06484, 203-944-2800

Contact: Rhodemann Li, Vice President

Date: December 31, 1995

Classification Name: Staple, Fixation, Bone

Common Name: Bone anchor

Proprietary Name: LM Anchor or other proprietary name

Predicate Devices: Mitek Surgical Products Mini Anchor (K921873 and K930892)
Li Medical Bone Anchor (K951233)

Device Description: Made from surgical grade stainless steel (316L), the LM Anchor is 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: Shoulder (bankart repair), Hand (ulnar or lateral collateral ligament reconstruction), Wrist (scapholunate ligament reconstruction), Foot (hallux valgus reconstruction), and Ankle (midfoot reconstructions)

Technical Comparison: The LM Anchor is similar to the Mitek Mini Anchor in its cylindrical shape, however, the bony purchase is accomplished by the LM Anchor through cantilevered beams versus nitinol arcs with the Mitek Mini Anchor.

Performance Data: Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek Mini Anchor.

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