LM BONE ANCHOR
Device Facts
| Record ID | K960439 |
|---|---|
| Device Name | LM BONE ANCHOR |
| Applicant | Li Medical Technologies, Inc. |
| Product Code | MBI · Orthopedic |
| Decision Date | Apr 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
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, tennis elbow, 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
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 procedures (shoulder, hand/wrist, foot/ankle, elbow, knee); provides mechanical fixation for tendons and ligaments; bony purchase achieved via cantilevered beams; implanted by surgeons during orthopedic repair procedures.
Clinical Evidence
Bench testing only. Pre-clinical pullout strength testing performed in cadaver specimens; mean pullout strength of LM Anchor compared to Mitek anchors showed 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 for bony purchase.
Indications for Use
Indicated for soft tissue to bone attachment in shoulder, hand/wrist, foot/ankle, elbow, and knee surgical procedures, including ligament and tendon repairs.
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 Anchor (K915889)
- Mitek Surgical Products SuperAnchor (K920213?)
- Li Medical Bone Anchor (K951233)
Related Devices
- K981755 — LM ANCHOR · Li Medical Technologies, Inc. · Jul 13, 1998
- K960448 — LM ANCHOR · Li Medical Technologies, Inc. · Apr 17, 1996
- K981764 — LM ANCHOR · Li Medical Technologies, Inc. · Jul 13, 1998
- K963812 — LM BONE ANCHOR (ORTHOPEDICS) · Li Medical Technologies, Inc. · Nov 12, 1996
- K960825 — LM ANCHOR OR OTHER PROPRIETARY NAME · Li Medical Technologies, Inc. · Apr 30, 1996
