(83 days)
Multitak SS Suture System
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No
The device description and performance studies focus on the mechanical properties and surgical application of a suture anchor, with no mention of AI or ML.
No
The device is a suture fixation system used in surgical procedures to attach soft tissue to bone, which is a structural and mechanical function, not a therapeutic one in the sense of treating or curing a disease or condition through non-surgical means. It facilitates repair rather than providing therapy itself.
No
The device is described as an anchor for soft tissue to bone suture fixation, which is a surgical repair function, not a diagnostic one.
No
The device description clearly describes a physical anchor and an introduction device, which are hardware components.
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 surgical device for fixing soft tissue to bone during various orthopedic procedures. This is a direct surgical intervention on the body.
- Device Description: The description details a physical implant (anchor) and its delivery system, used to secure sutures within bone. This is a mechanical device for surgical repair.
- 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 samples, 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) for surgical repair.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Rotator cuff tear repairs
- Biceps tenodesis .
Foot and Ankle
- Lateral instability repairs/reconstructions -
Elbow
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- Biceps tendon reattachment -
Knee
1
- Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament
Product codes
Not Found
Device Description
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pullout tension testing of the Multitak Suture System was performed in cadaver bone and compared to similar testing of the predicate device. Results demonstrated that the performance of the Multitak Suture System was equal to or better than the performance of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Multitak SS Suture System, marketed by Bonutti Research.
Reference Device(s)
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
§ 888.3040 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
K964532
Summary of Safety and Effectiveness Multitak Suture System™
FEB - 3 1997
-
Submitted by .
Bonutti Research 1303 Evergreen Ave. Effingham, IL 62401 -
Prepared by .
Lynnette Whitaker Director Regulatory Affairs/Quality Assurance -
. Date
January 29, 1997 -
Trade Name .
Multitak Suture System -
. Common Name
Soft Tissue Anchor -
. Classification Name
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener -
Predicate Devices .
- . Multitak SS Suture System, marketed by Bonutti Research.
-
Device Description .
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
1
.
Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Rotator cuff tear repairs ।
- Biceps tenodesis .
Foot and Ankle
- Lateral instability repairs/reconstructions -
Elbow
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- Biceps tendon reattachment -
Knee
1
- Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament
Performance Data .
Pullout tension testing of the Multitak Suture System was performed in cadaver bone and compared to similar testing of the predicate device. Results demonstrated that the performance of the Multitak Suture System was equal to or better than the performance of the predicate device.