(20 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical procedures, with no mention of AI or ML.
No.
The device description indicates it is an anchor system intended for surgical repair of torn ligaments and tendons, which are structural repairs, not therapeutic treatments.
No
The device, VERSALOCK Anchor, is an implant used for orthopedic repairs (e.g., rotor cuff repair, ligament repair) and is described as an "Anchor System." Its function is structural support and reattachment of tissues, not the diagnosis of medical conditions.
No
The device description explicitly details physical components like an anchor, inserter shaft, anvil, threader tab, suture, and a reusable deployment gun. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical repair of ligaments and tendons in the shoulder, knee, and elbow. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a surgical anchor system, including an anchor, inserter, and suture. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used for surgical repair within the body.
N/A
Intended Use / Indications for Use
The Versalok Peek Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The Versalok Peek Anchor System includes the Versalok Peek Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.
The VERSALOK Anchor System offers several additional clinical benefits as the anchor allows the surgeon to fix the tissue without tying knots and the delivery system allows the surgeon to control the tension placed on the tissue with the tension wheel of the deployment gun.
Technologies characteristics including material, design, packaging and indications are the same as the predicate cleared devices and use similar or identical material and packaging as the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Elbow
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)
Verification activities were performed on the implant or its predicates. Testing includes pull out testing, shelf life, sterilization and biocompatibility.
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Versalok Peek Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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.
Trident Anchor (K060914), Versalok Ti Anchor (K063478), Arthrex Pushlock Anchor (K063479)
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
510(k) SUMMARY
KI00532
ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌ
Versalok Peek Anchor
| Submitter's Name and Address: | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MAR 1 7 2010 |
| Contact Person | Kristine Christo
Regulatory Affairs Project Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone: 508-828-3359
Facsimile: 508-977-6911
e-mail: kchristo@its.jnj.com
Prepared: 2/24/10 |
| Name of Medical Device | Classification Name: Fastener, Fixation, Nondegradable, Soft
Tissue Smooth or threaded metallic bone
fixation fasteners
Common/Usual Name: Bone Anchor
Proprietary Name: Versalok Peek Anchor |
| Substantial Equivalence | Versalok Peek Anchor is substantially equivalent to:
Trident Anchor (K060914)
Versalok Ti Anchor (K063478)
Arthrex Pushlock Anchor (K063479) |
| Device Classification | This device carries an FDA product code MBI and HWC, and is
classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or
threaded metallic bone fixation fasteners under 21 CFR 888.3040. |
| Device Description | The Versalok Peek Anchor System includes the Versalok Peek Anchor,
which will be presented sterile, pre-mounted on an inserter shaft w/anvil |
510(k) Premarket Notification: Special
Versalok Peek Anchor ConfidentialVersalok Peek Anchor
1
.
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with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.
The VERSALOK Anchor System offers several additional clinical benefits as the anchor allows the surgeon to fix the tissue without tying knots and the delivery system allows the surgeon to control the tension placed on the tissue with the tension wheel of the deployment gun.
Technologies characteristics including material, design, packaging and indications are the same as the predicate cleared devices and use similar or identical material and packaging as the predicates.
Indications for Use
Nonclinical testing:
Safety and Performance
Predicate Comparison
The Versalok Peek Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment
Verification activities were performed on the implant or its predicates. Testing includes pull out testing, shelf life, sterilization and biocompatibility.
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Versalok Peek Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
The proposed Versalok Peek Anchor is compared to the predicate Trident Anchor (K063478), Versalok Anchor (K060914) and Arthrex Pushlock (K063479) below.
510(k) Premarket Notification: Special Versalok Peek Anchor
Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
MAR 1 7 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
DePuy Mitek % Ms. Kristine Christo Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767
Re: K100532 Trade/Device Name: VERSALOCK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: February 24, 2010 Received: February 25, 2010
Dear Ms. Christo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Kristine Christo
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
VERSALOCK Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100532