(47 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical use of a bone anchor system, with no mention of AI or ML.
Yes
The device is indicated for the repair of various instabilities and tears in different anatomical sites, which refers to the treatment or management of an injury or disease.
No
The device description and intended use indicate that the ANCHORLOK™ II Soft Tissue Anchor System is used for the repair of various soft tissue instabilities, acting as a physical anchor for sutures during surgical procedures. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a "single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ANCHORLOK™ II Function: The ANCHORLOK™ II Soft Tissue Anchor System is a surgical implant used to physically repair damaged soft tissues in various joints. It is a mechanical device used in vivo (within the living body) during surgery.
- Lack of Specimen Analysis: The description of the ANCHORLOK™ II does not involve the analysis of any biological specimens. Its function is purely structural and mechanical.
Therefore, based on the provided information, the ANCHORLOK™ II Soft Tissue Anchor System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following: - 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: - repair of elbow instability secondary to biceps tendon detachment, temnis elbow, or ulnar or radial collateral ligament tear/separation: - repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or postcrior oblique ligament, or secondary to iliotibial band tenodesis: - 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
Not Found
Device Description
The ANCHORLOK™ II 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 surgeon uses suure according to preference. The anchor is manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Hand/Wrist, Knee, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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
The 7.5mm anchor was tested according to Draft Guidance Document for Tasting Bone Anchor Devices April 1, 1993. The 2.5mm and 7.5mm ANCHORLOK™ II Soft Tissue Anchors were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 7.5mm anchor was tested according to Draft Guidance Document for Tasting Bone Anchor Devices April 1, 1993. The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor. The 2.5mm and 7.5mm ANCHORLOK™ II Soft Tissue Anchors were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the in vivo performance of Nylon™ monofilament sunures meets or exceeds the values established by USP for these devices.
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.
ANCHORLOKIN Polyester Suture Soft Tissue Anchor System
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
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
(96321
Image /page/0/Picture/2 description: The image shows a black and white logo that resembles the letter 'W'. The logo is composed of two triangles that are connected at the top. A white line runs diagonally through the center of the logo, creating a sense of depth. A small circle with the letter 'R' inside is located at the bottom right corner of the logo.
510(k) Summary
HEDICAL TECHNOLOGY, INC. AIRLINE
REINGTON, IN 38002 01-867-997
ROAD
Contact Person: Date Prepared:
Cristie Manuel September 30, 1996
Trade/Proprietary Name: Common Name: Product Classification: Predicate Device:
ANCHORLOK™ II Soft Tissue Anchor System Fastener, fixation, nondegradable, soft tissue Class II ANCHORLOKIN Polyester Suture Soft Tissue Anchor System
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™ II 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 surgeon uses suure according to preference. The anchor is manufactured from titanium alloy.
The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following:
- 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:
- repair of elbow instability secondary to biceps tendon detachment, temnis elbow, or ulnar or radial collateral ligament tear/separation:
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or postcrior oblique ligament, or secondary to iliotibial band tenodesis:
- 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 Summarv
The 7.5mm anchor was tested according to Draft Guidance Document for Tasting Bone Anchor Devices April 1, 1993. The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor.
The 2.5mm and 7.5mm ANCHORLOK™ II Soft Tissue Anchors were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the in vivo performance of Nylon™ monofilament sunures meets or exceeds the values established by USP for these devices.