(28 days)
VERSALOK 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
The Versalok Anchor System includes the Versalok 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 could be provided with a variety of #2 suture options.
This 510(k) summary for the Versalok Anchor does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
The document is a standard 510(k) submission summary, primarily focused on establishing substantial equivalence to predicate devices. It discusses:
- Submitter and Contact Information: DePuy Mitek, Ruth C. Forstadt.
- Device Name: Versalok Anchor.
- Classification: Orthopedic fasteners (Smooth or threaded metallic bone fixation fastener).
- Substantial Equivalence: States it is substantially equivalent to the Trident Anchor (K060914).
- Device Description: Describes the anchor, inserter, threader tab, suture, and deployment gun.
- Indications for Use: Lists specific applications in the shoulder, knee, and elbow.
- Safety and Performance: Simply states that "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.
The document focuses on regulatory classification and substantial equivalence, not on a detailed performance study with quantifiable acceptance criteria. For medical devices, "performance testing" in the context of a 510(k) often refers to bench testing (e.g., mechanical strength, pull-out strength) to demonstrate that the new device performs similarly to or better than the predicate device under simulated conditions, rather than a clinical study with human patients. However, the exact details of such testing, including acceptance criteria and results, are not included in this summary.
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K663478112
510(k) SUMMARY
.
Versalok Anchor
DEC 1 5 2006
:
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | |
|---|---|---|
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-977-3988Facsimile: 508-828-3750e-mail: rforstad@dpyus.jnj.com) | |
| Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners |
| Common/Usual Name:Proprietary Name: | Bone AnchorVersalok Anchor | |
| Substantial Equivalence | Versalok Anchor is substantially equivalent to:Trident Anchor (K060914) | |
| Device Classification | The Versalok Anchor device carries an FDA product code MBI andHWC, and is classified as Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bone fixation fasteners under 21CFR 888.3040.Sutures, classified by the FDA, are Class II Medical Devices. Thesutures (that are provided with the anchor) are classified as follows:Orthocord suture (a combination of PDS and Polyethylene suture):PDS Suture carries an FDA product code NEW, and is classified asabsorbable surgical suture, polydiaxanone under 21 CFR 878.4840.Polyethylene suture carries an FDA product code GAT, and is classifiedunder 21 CFR 878.5000. |
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Panacryl Suture carries an FDA product code NEW, and is classified as suture, absorbable synthetic polyglycolic acid under 21 CFR 878.4493. Ethibond suture carries an FDA product code of GAS, and is classified as suture, non-absorbable synthetic polyester under 21 CFR 878.5000. The Versalok Anchor System includes the Versalok Anchor, which will Device Description 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 could be provided with a variety of #2 suture options. The Versalok Anchor is indicated for use in the following: Indications for Use 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 Results of performance and safety testing have demonstrated that the Safety and Performance modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Versalok Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings, rendered in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2006
DePuy Mitck % Ruth C. Forstadt, RAC Project Management Lead, Regulatory Affairs Raynham, Massachusetts 02767
Re: K063478
Trade/Device Name: Versalok Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC, MBI, NEW, GAT, GAS, GAM Dated: November 16, 2006 Received: November 17, 2006
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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,
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Page 2 - Ruth C. Forstadt, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Names: Versalok Anchor
VERSALOK 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
Mark A. Mellman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063478
Prescription Use (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) Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Premarket Notification: Special Versalok Anchor
Confidential
§ 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.