(14 days)
The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.
The Panalok RC Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone with enhanced suture-sliding capabilities. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a 510(k) summary for the Panalok RC Loop Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request with the given input.
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K041065 PG142
MAY - 7 2004
510(k) Summary - Panalok RC Loop Anchor
| Submitter's Name and Address: | DePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2794Facsimile: 781-278-9578e-mail: abarford@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of bone to soft tissueProprietary Name: Panalok RC Loop Anchor |
| Device Classification | Screw, Fixation, Bone Staple devices have been classified as Class II, GAM and MAI according to 21 CFR 888.3030. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Screw, Fixation, Bone Staple devices. |
| Indications for Use | The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:Shoulder: Rotator cuff repair. |
| Device Description | The Panalok RC Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone with enhanced suture-sliding capabilities. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer. |
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KACH065 pgehy?
| Substantial Equivalence | Based on the type of changes being made and the fact that the Panalok RC Loop Anchor represents the same fundamental scientific technology as the existing S BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the Panalok RC Loop Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013) manufactured by DePuy Mitek. |
|---|---|
| Safety | Biocompatibility studies have demonstrated the Panalok RC Loop |
Anchor to be non-toxic, non-irritating, and non-cytotoxic.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Ms. Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041065
Trade/Device Name: Panalok RC Loop Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR and MAI Dated: April 5, 2004 Received: April 23, 2004
Dear Ms. Barford:
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 commercc 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Allyson Barford
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 (301) 594-4659. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. 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): K041065
Device Names:
Panalok RC Loop Anchor
Indications for Use:
The Mitek Panalok RC Loop Anchors arc indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.
O. Mark N. Mellam
Division of General, Restorative, and Neurological Devices
510(k) Number K041065
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF.)
Prescription Use
OL
Over-the-Counter Use Uh
Special 510(k) Premarket Notification: Panalok RC Loop Anchors DePuy Mitck
CONFIDENTIAL
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.