(62 days)
Not Found
No
The device description and intended use are for a physical suture anchor made of resorbable material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on non-clinical testing of the physical anchor's properties.
Yes
The device is clearly indicated for various soft tissue reattachment procedures to treat injuries and conditions across multiple anatomical sites, which is a therapeutic function.
No
Explanation: The device is described as a suture anchor used for reattaching soft tissue during surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture anchor made of resorbable material and preloaded with sutures, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures to reattach soft tissue in various anatomical locations. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is a suture anchor made of resorbable material with preloaded sutures. This is a surgical implant, not a diagnostic reagent or instrument used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulner or radial collateral ligament reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
JDR, HWC
Device Description
The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist/Hand, Ankle/Foot, 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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Climical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LactoScrew™ Screw Anchor (K033355)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
K.061389 page 141
Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, bold, sans-serif font, with the letters connected. Below it, in a smaller font, is the text "ORTHOPEDICS, INC.", also in sans-serif font. The logo is simple and professional, likely representing a company in the medical or orthopedic field.
JUL 1 9 2006
510(k) Summary
| Preparation Date: | May 15, 2006 |
|---|---|
| Applicant/Sponsor: | Arthrotek, Inc., |
| (A Wholly Owned Subsidiary of Biomet, Inc.) | |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, Indiana 46581-0587 | |
| Contact Person: | Lester F. Padilla |
| Proprietary Name: | ALLthread™ LactoSorb® Suture Anchor |
| Common Name: | Suture anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue (21 CFR 888.3030) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- . LactoScrew™ Screw Anchor (K033355)
Device Description: The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.
Intended Use: Indications for the ALLthread™ Lacto:Sorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio:lavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenndesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Medial collateral ligament repair, lateral collateral iigament repair, posterior obligue ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.
Summary of Technologies: The ALLthread™ Lacto:iorb® Suture Anchors have similar or identical technological characteristics (design, materials, functional performance) as the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Climical Testing: None provided as a basis for substantial equivalence.
MALING ADDRESS PO. Box 587
Warsaw, IN 46581 0587
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All trademarks are property of Arthrotek, Inc.
SHIPPING ADDRESS 56 E. Bell Drive W:ursaw, IN 46582,
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