(64 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical applications of a bone anchor, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is used for soft tissue to bone attachment in surgeries to repair ligaments or tendons, which is a structural repair rather than a therapeutic treatment.
No
The device description and intended use indicate that this is a surgical anchor designed for soft tissue to bone attachment, not for diagnosing medical conditions.
No
The device description explicitly states it is made from surgical grade stainless steel or titanium and is designed with a crown and center pin, indicating it is a physical implantable device, not software.
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 clearly describes the device as being used for surgical procedures to attach soft tissue to bone in various anatomical locations (shoulder, hand/wrist, foot/ankle, elbow, knee). This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and design of a surgical anchor, which is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or medical device used in surgical procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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).
Product codes
Not Found
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K904436, K951233, K951472, K953764, K960448, K960439, K960825
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
NOV 1 2 1996
510(K) SUMMARY
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800 |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Date: | Rhodemann Li, Vice President
October 30, 1996 |
| Classification Name:
Common Name:
Proprietary Name: | Staple, Fixation, Bone
Bone anchor
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 | |
l
1
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.