← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K960439 # LM BONE ANCHOR (K960439) _Li Medical Technologies, Inc. · MBI · Apr 18, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K960439 ## Device Facts - **Applicant:** Li Medical Technologies, Inc. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Apr 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K915889.md)) - Mitek Surgical Products SuperAnchor ([K920213](/device/K920213.md)?) - Li Medical Bone Anchor ([K951233](/device/K951233.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Li Medical Technologies Inc. 4 Armstrong Road Shelton, Connecticut 06484 203-944-2800 K960439 # APR 18 1996 # 510(K) SUMMARY ![img-0.jpeg](img-0.jpeg) Li Medical 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 GII Anchor (K915889) Mitek Surgical Products SuperAnchor (K920213?) 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, 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). Technical Comparison: The LM Anchor is similar to the Mitek anchors in its cylindrical shape, however, the bony purchase is accomplished by the LM Anchor 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 was substantially equivalent to the mean pullout strength of the Mitek anchors. Fax 203-944-2806 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K960439](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K960439) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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