(69 days)
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No
The summary describes a mechanical anchor system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "ANCHORLOK™ RL Soft Tissue Anchor System" used for the "repair" of various instabilities and tears in different anatomical sites, including "Female urinary incontinence due to urethral hypermobility." These uses directly involve treating or correcting medical conditions, making it a therapeutic device.
No
The device, ANCHORLOK™ RL Soft Tissue Anchor System, is described as a "single use, sterile kit consisting of a bone anchor" used for the repair of various soft tissue instabilities. Its function is to provide mechanical support and stabilization, not to identify or diagnose medical conditions.
No
The device description explicitly states it is a "single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve" and that the anchor is "manufactured from titanium alloy." This clearly indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in the surgical repair of various soft tissue instabilities in different anatomical locations (shoulder, elbow, hand/wrist, knee, foot/ankle, and female urinary incontinence). This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is a bone anchor made of titanium alloy, designed for surgical implantation to secure soft tissues. This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide diagnostic information. The performance study focuses on mechanical pullout strength, which is relevant to its surgical function, not diagnostic accuracy.
In summary, the ANCHORLOK™ RL Soft Tissue Anchor System is a surgical device used for repair and stabilization, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, . acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or . radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, . ulnar collateral ligament, or radial collateral ligament;
- Female urinary incontinence due to urethral hypermobility; .
- In the repair of knee instability secondary to tear or separation of the medial collateral ligament, . lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to illiotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral . stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Product codes
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Device Description
The ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The anchor is manufactured from titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder, Elbow, Hand/Wrist, Pubis, Knee, Foot/Ankle
Indicated Patient Age Range
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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
In vitro pullout strength testing in the pubis indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Statak™ anchor.
Key Metrics
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Predicate Device(s)
ANCHORLOK™ RL Soft Tissue Anchor System, Statak™ Soft Tissue Attachment Device
Reference Device(s)
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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/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the word "WRIGHT" in bold, uppercase letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." Underneath that is the address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and the phone number "901-867-9971".
- 6 1997
510(k) Summary
Contact Person: Date Prepared:
Cristie Manuel January 30, 1997
Classification Name: Predicate Device:
Trade/Proprietary Name: ANCHORLOK™ RL Soft Tissue Anchor System Fastener, fixation, nondegradable, soft tissue ANCHORLOK™ RL Soft Tissue Anchor System manufactured for Wright Medical Technology, Inc., and the Statak™ Soft Tissue Attachment Device manufactured by Zimmer.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/Intended Use
The ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The anchor is manufactured from titanium alloy.
The ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, . acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or . radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, . ulnar collateral ligament, or radial collateral ligament;
- Female urinary incontinence due to urethral hypermobility; .
- In the repair of knee instability secondary to tear or separation of the medial collateral ligament, . lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to illiotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral . stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Testing Summary
Conclusion: In vitro pullout strength testing in the pubis indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Statak™ anchor.