(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a surgical anchor, with no mention of AI or ML.
Yes
The device is described as a surgical anchor used to reattach soft tissue to bone (e.g., in rotator cuff repair, ligament reconstruction), which are procedures intended to treat or alleviate a medical condition.
No
The device description indicates it is an implant (anchor) designed for soft tissue to bone attachment, used in surgical repairs. Its function is to facilitate mechanical attachment, not to diagnose a condition.
No
The device description explicitly states it is made from surgical grade stainless steel and is a physical anchor, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes surgical procedures for repairing soft tissue to bone in various anatomical locations (shoulder, hand/wrist, foot/ankle, elbow, knee). This is a therapeutic/surgical device, not a diagnostic one.
- Device Description: The device is a surgical implant made of stainless steel designed for soft tissue attachment. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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).
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Hand/Wrist, Foot/Ankle, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Mitek Surgical Products GII Anchor (K915889), Mitek Surgical Products SuperAnchor (K920213?), Li Medical Bone Anchor (K951233)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
Li Medical Technologies Inc.
4 Armstrong Road Shelton, Connecticut 06484
203-944-2800
APR 1 8 1998
510(K) SUMMARY
| | Device Sponsor:
Contact:
Date: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800
Rhodemann Li, Vice President
December 31, 1995 |
|------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Li Medical | Classification Name:
Common Name:
Proprietary Name: | Staple, Fixation, Bone
Bone anchor
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. |