(140 days)
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The intended use lists several surgical repair procedures, indicating the device is used in the treatment of injuries.
No
The device is an absorbable anchor used for surgical fixation of ligaments and tendons, not for diagnosing medical conditions.
No
The device description clearly states it is a physical anchor made of PLA, indicating it is a hardware 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 surgical procedures for repairing and reconstructing ligaments and tendons in the shoulder, knee, and ankle. This is a therapeutic and structural function within the body.
- Device Description: The device is a physical anchor made of PLA, designed for fixation of sutures within bone. This is a surgical implant.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
SHOULDER
- Rotator Cuff repair
- Capsule shift/capsulo-labral reconstruction
KNEE - Extra-capsular repairs and reattachment of:
· medial collateral ligament
- lateral collateral ligament .
- · posterior oblique ligament and joint capsule to tibia
- joint capsule closure to the anterior proximal tibia ●
-
- Extra-capsular construction, ITB tenodesis
-
- Patellar ligament and tendon avulsion repairs
ANKLE
- Patellar ligament and tendon avulsion repairs
-
- Achilles tendon repair/reconstruction
Product codes
Not Found
Device Description
- FUNCTION
Fixation of USP #2 suture below bone surface using unique design, insertion techniques, and materials.
DEVICE DESIGN
The Mitek Absorbable Toggle Anchor is cylindrical/conical in shape with an overall length of 0.44" x 0.11" in diameter.
MATERIALS USED
The Mitek Absorbable Toggle Anchor is molded from Poly-lactiac (PLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Ankle
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
Mitek Absorbable Toggle Anchor pull tests from cadaver bone provided an average failure load of 32 pounds.
Key Metrics
Not Found
Predicate Device(s)
MITEK® STEALTH ANCHOR™
Reference Device(s)
MITEK® WEDGE ANCHOR
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
FEB 2 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK® ABSORBABLE TOGGLE ANCHOR
SUBMITTER
NAME ADDRESS TEL# CONTACT DATE
Mitek Surgical Products, Inc. 60 Glacier Drive, Westwood, MA 02090 617-461-9700 Edward F. Kent, Vice President, Regulatory Affairs October 4, 1996
NAME OF DEVICE
Staple, Fixation, Bone CLASSIFICATION NAME Appliance for reconstruction of bone to soft COMMON NAME tissue. MITEK® ABSORBABLE TOGGLE ANCHOR PROPRIETARY NAME MITEK® STEALTH ANCHOR™ PREDICATE DEVICE MITEK® WEDGE ANCHOR
DESCRIPTION OF THE DEVICE
- FUNCTION
Fixation of USP #2 suture below bone surface using unique design, insertion techniques, and materials.
DEVICE DESIGN
DEVICE DEGION
The Mitek Absorbable Toggle Anchor is cylindrical/conical in shape with an overall length of 0.44" x 0.11" in diameter.
MATERIALS USED
The Mitek Absorbable Toggle Anchor is molded from Poly-lactiac (PLA). INTENDED USE
SHOULDER
-
Rotator Cuff repair
-
Capsule shift/capsulo-labral reconstruction KNEE
-
Extra-capsular repairs and reattachment of:
· medial collateral ligament
- lateral collateral ligament .
- · posterior oblique ligament and joint capsule to tibia
- joint capsule closure to the anterior proximal tibia ●
-
- Extra-capsular construction, ITB tenodesis
-
- Patellar ligament and tendon avulsion repairs
ANKLE
-
- Achilles tendon repair/reconstruction
1
COMPARISON TO PREDICATE DEVICE
The Mitek Absorbable Toggle Anchor is similar to the Mitek Stealth and Wedge Anchor in materials and to all other Mitek Anchors in use and function, i.e., to "hold" tissue, with sutures that are locked into a predrilled bone hole, for a period of rehabilitation.
DESCRIPTION OF NON CLINICAL TESTS
Mitek Absorbable Toggle Anchor pull tests from cadaver bone provided an average failure load of 32 pounds.