LM ANCHOR OR OTHER PROPRIETARY NAME
Device Facts
| Record ID | K960825 |
|---|---|
| Device Name | LM ANCHOR OR OTHER PROPRIETARY NAME |
| Applicant | Li Medical Technologies, Inc. |
| Product Code | MBI · Orthopedic |
| Decision Date | Apr 30, 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), Bladder Neck Suspension.
Device Story
LM Anchor; surgical grade 316L stainless steel bone anchor; crown and center pin design for suture passage; soft tissue to bone attachment; used in orthopedic reconstructive surgeries (shoulder, hand/wrist, foot/ankle, elbow, knee) and bladder neck suspension; operated by surgeons; provides mechanical fixation of soft tissue to bone; pullout strength comparable to predicate anchors.
Clinical Evidence
Bench testing only. Pre-clinical pullout strength testing performed in cadaver specimens; mean pullout strength of LM Anchor found substantially equivalent to Mitek predicate anchors.
Technological Characteristics
Material: 316L surgical grade stainless steel. Form factor: Cylindrical bone anchor with crown and center pin. Fixation mechanism: Cantilevered beams for bony purchase. Non-powered, mechanical device.
Indications for Use
Indicated for soft tissue to bone attachment in shoulder, hand/wrist, foot/ankle, elbow, and knee reconstructive procedures, and 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 Anchor (K915889)
- Mitek Surgical Products SuperAnchor (K920213?)
- Li Medical Bone Anchor (K951233)
Related Devices
- K981764 — LM ANCHOR · Li Medical Technologies, Inc. · Jul 13, 1998
- K960448 — LM ANCHOR · Li Medical Technologies, Inc. · Apr 17, 1996
- K981755 — LM ANCHOR · Li Medical Technologies, Inc. · Jul 13, 1998
- K960439 — LM BONE ANCHOR · Li Medical Technologies, Inc. · Apr 18, 1996
- K963812 — LM BONE ANCHOR (ORTHOPEDICS) · Li Medical Technologies, Inc. · Nov 12, 1996
