(67 days)
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.
Yes
The device is described as a soft tissue-to-bone suture fixation device for various repairs and reconstructions across multiple anatomical sites, directly participating in the treatment of medical conditions.
No
The device is a surgical implant designed for soft tissue-to-bone fixation, specifically for reattaching ligaments and tendons. It is a treatment device, not one used for diagnosis.
No
The device description clearly describes a physical anchor, suture, and driver, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a surgical anchor used for soft tissue-to-bone suture fixation in various anatomical locations (Shoulder, Foot and Ankle, Elbow, Wrist, Hand, Knee). It is a physical implant used during surgery.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue-to-bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- SLAP lesion repairs -
- Acromio-clavicular separation repairs -
- -Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions -
- Biceps tenodesis -
- Deltoid repairs -
Foot and Ankle
- Medial or lateral instability repairs/reconstructions -
- Achilles tendon repairs/reconstructions -
- -Midfoot reconstructions
- Hallus valgus reconstructions -
Elbow, Wrist, and Hand
- -Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- -Biceps tendon reattachment
Knee
- Extra-capsular repairs: -
- -- Medial collateral ligament
- -- Lateral collateral ligament
- -- Posterior oblique ligament
- Iliotibial band tenodesis -
- Patellar tendon repairs -
Product codes
Not Found
Device Description
The Statak Soft Tissue Attachment Device anchor has a diameter of 2.5 mm, is self-tapping, self-drilling, and fully threaded. A double strand, braided, nonabsorbable Size No. 2-0 suture is attached to an eyelet at the end of the anchor. A disposable driver which can be attached to a powered handpiece holds the excess suture and delivers the anchor directly into the bone. When the driver is removed, the suture strands are left emerging from the bone. The strands are then used to secure the soft tissue to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist, and Hand, 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)
The Statak Soft Tissue Attachment Device was tested by tension loading the suture in the hand bones of cadaver specimens, with the results compared to a suture-only tenodesis procedure in similar bone. The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K926384, K953877, K9338892, K904436
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font.
ﻤﻌﻬﺪ ﺍ
AUG 2 T 1996
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Statak Soft Tissue Attachment Device
962397
. Submitted by:
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
. Prepared by:
Lynnette Whitaker Manager Regulatory Affairs
-
. Date:
June 17, 1996 -
Trade Name: .
Statak® Soft Tissue Attachment Device
. Common Name:
Soft Tissue Anchor
. Classification Name:
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
- . Predicate Devices:
1
Device Description:
.
The Statak Soft Tissue Attachment Device anchor has a diameter of 2.5 mm, is self-tapping, self-drilling, and fully threaded. A double strand, braided, nonabsorbable Size No. 2-0 suture is attached to an eyelet at the end of the anchor. A disposable driver which can be attached to a powered handpiece holds the excess suture and delivers the anchor directly into the bone. When the driver is removed, the suture strands are left emerging from the bone. The strands are then used to secure the soft tissue to the bone.
Intended Use:
The devices are intended for soft tissue-to-bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- SLAP lesion repairs -
- Acromio-clavicular separation repairs -
- -Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions -
- Biceps tenodesis -
- Deltoid repairs -
Foot and Ankle
- Medial or lateral instability repairs/reconstructions -
- Achilles tendon repairs/reconstructions -
- -Midfoot reconstructions
- Hallus valgus reconstructions -
Elbow, Wrist, and Hand
- -Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- -Biceps tendon reattachment
Knee
- Extra-capsular repairs: -
2
- -- Medial collateral ligament
- -- Lateral collateral ligament
- -- Posterior oblique ligament
- Iliotibial band tenodesis -
- Patellar tendon repairs -
Performance Data:
The Statak Soft Tissue Attachment Device was tested by tension loading the suture in the hand bones of cadaver specimens, with the results compared to a suture-only tenodesis procedure in similar bone. The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure.
RA06601K.510