(81 days)
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Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any computational analysis of data.
Yes
The device is used to repair various instabilities and injuries in different anatomical sites, which indicates a therapeutic purpose.
No
The device description and intended use indicate that the ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is used for the repair of instabilities in various anatomical sites by anchoring soft tissue. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "single use, sterile device" and describes physical components like anchors made of titanium alloy and drivers, indicating it is a 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 clearly describes the device as being used in vivo (within the body) for surgical repair of soft tissue injuries and instabilities in various anatomical locations. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The device is described as a soft tissue anchor system made of titanium alloy, designed to be implanted during surgery. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ANCHORLOK™ and 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 uninary incontinence due to urethral hypermobility;
- In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, pattellar tendon, or posterior oblique ligament, or secondary to iliotibial 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:
- Lateral canthoplasty
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile device, available in two configurations: the ANCHORLOK™, which is provided sterile, preloaded with suture and a disposable, single use driver, and the ANCHORLOK™ RL, which is provided sterile and is designed for use with reusable, resterilizable driver instrumentation, and suture provided by the surgeon. The anchors for both configurations are made of 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, urethra, knee, foot/ankle
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
In vitro pullout strength testing indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor.
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.
Not Found
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
§ 888.3040 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 a stylized letter "W" logo. The "W" is formed by three thick, black, angled lines that converge at the bottom, creating a triangular shape. A small registered trademark symbol is located at the bottom center of the "W".
Image /page/0/Picture/1 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002". The text is in a sans-serif font and is black on a white background. The text is arranged in a vertical format, with the company name at the top, followed by the address.
JUN 27 1997
...
510(k) Summary
Contact Person: Date Prepared:
Cristie Manuel April 4, 1997
Classification Name: Predicate Device:
Trade/Proprietary Name: ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System Fastener, fixation, nondegradable, soft tissue ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System manufactured for Wright Medical Technology, Inc., and the Mitek Anchor manufactured by Mitek Surgical Products, Inc.
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™ and ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile device, available in two configurations: the ANCHORLOK™, which is provided sterile, preloaded with suture and a disposable, single use driver, and the ANCHORLOK™ RL, which is provided sterile and is designed for use with reusable, resterilizable driver instrumentation, and suture provided by the surgeon. The anchors for both configurations are made of titanium alloy.
The ANCHORLOK™ and 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 illotibial 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;
- . Lateral canthoplasty.
Testing Summary
Conclusion: In vitro pullout strength testing indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor.
000056
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, superimposed over a circular emblem. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christie Manuel 'Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
JUN 27 1997
K971282 Re : Anchorlok and Anchorlok RL Soft Tissue Anchor System Requlatory Class: II Product Codes: MBI and HWC Dated: April 4, 1997 Received: April 7, 1997
Dear Ms. Manuel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Marie Schroeder, MS, PT
M.D. Celia M. Witten, Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Wright Medical Technology, Inc. Premarket Notification
ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System, Expanded Indication
- Indications for Use of the Device C.
510(k) Number (if known): _ 长分71282
ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Device Name: Anchor System
Indications for Use:
The ANCHORLOK™ and 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 uninary 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 iliotibial 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:
- Lateral canthoplasty
continue on another page if needed) (Please do not write below this line-* *
Concurrence of CDRH, Office of Device Evaluation (ODE)
Man-F. Helmoller MSSt. des Amin
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971282
Prescription Use X (Per 21 CFR 801.109) Or
Over-the-Counter Use
0000009
(Optional Format 1-2-96)