LM BONE ANCHOR (ORTHOPEDICS)

K963812 · Li Medical Technologies, Inc. · MBI · Nov 12, 1996 · Orthopedic

Device Facts

• Record ID: K963812
• Device Name: LM BONE ANCHOR (ORTHOPEDICS)
• Applicant: Li Medical Technologies, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UltraFix RC Shoulder (rotator cuff repair) UltraFix Mini Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament) UltraFix Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).

Device Story

Bone anchor system for soft tissue-to-bone attachment; utilizes surgical grade 316L stainless steel or 6Al-4V ELI titanium. Device features crown and center pin for suture passage. Anchoring mechanism employs cantilevered beams for bony purchase. Used by orthopedic surgeons in clinical settings for various ligament and tendon repairs across shoulder, hand, wrist, elbow, foot, ankle, and knee. Provides mechanical fixation to facilitate tissue healing.

Clinical Evidence

Bench testing only. Pre-clinical pullout strength testing performed in cadaver specimens. Results showed mean pullout strength of LM Anchor Products is substantially equivalent to Mitek predicate anchors.

Technological Characteristics

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

Indications for Use

Indicated for soft tissue to bone attachment in orthopedic procedures including rotator cuff repair, ligament reconstruction (hand, wrist, elbow, knee, ankle), and tendon repair in patients requiring surgical fixation.

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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# 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 (6A1-4V 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 | Shoulder (rotator cuff repair) |
| UltraFix Mini | Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament) |
| UltraFix | Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis). |

Technical Comparison: The LM Anchor Products are similar to the Mitek anchors in its cylindrical shape, however, the bony purchase is

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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.