PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR

{0}------------------------------------------------ NOV 2 2 2006 ## 510(k) SUMMARY ## Panalok RC Quickanchor Plus w/ Orthocord Panalok RC Quickanchor Plus Dual w/ Orthocord Panalok Anchor w/ Orthocord | Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Kristine Christo<br>Senior Regulatory Affairs Specialist<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | | | Telephone:<br>508-828-3359<br>Facsimile:<br>508-977-6911<br>e-mail:<br>KChristo@Dpyus.jnj.com | | Name of Medical Device | Classification Name:<br>Screw, Fixation, Bone Staple<br>Fastener, Fixation, Biodegradable, Soft Tissue | | | Common/Usual Name:<br>Appliance for reconstruction of soft<br>tissue to bone | | | Proprietary Name:<br>Panalok Quickanchor Plus<br>Panalok RC QuickAnchor Plus Dual Suture<br>Panalok Anchor | | Substantial Equivalence | Panalok RC Quickanchor Plus (with ORTHOCORD) and Panalok RC<br>Quickanchor Plus Dual Suture (with ORTHOCORD) are substantially<br>equivalent to:<br>Panalok RC Quickanchor Plus, K041117 , manufactured by DePuy<br>Mitek. | | | Panalok Anchor (with ORTHOCORD) is substantially equivalent to:<br>Panalok Anchor, K970896 , manufactured by DePuy Mitek. | | Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical<br>Devices under the generic category of Single/Multiple component | | 510(k) Premarket Notification: Special | Confidential | | | metallic bone fixation appliances and accessories. | | | Panalok RC Quickanchor Plus carry FDA product code JDR, and is<br>classified as a fixation screw/bone staple under 21 CFR 888.3030. | | | Panalok Anchor carry FDA product code MAI, and is classified as a<br>Fastener, fixation biodegradable, soft tissue under 21 CFR 888.3030 | | Device Description | Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor<br>Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded,<br>PLA disposable suture anchor/ inserter assemblies designed to allow<br>soft tissue repair to bone. The anchors are an identical anchors as that<br>of the Panalok RC Anchor Plus (K041117) and Panalok Anchor<br>(K970896) in design, configuration and dimensions. The anchor<br>system may be sold with Ethibond Suture, Panacryl Suture, Orthocord<br>Suture. | | Indications for Use | The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek<br>Panalok RC QuickAnchor Plus Dual Suture with Orthocord are<br>intended for fixation of USP size #2 suture to bone for the indications<br>listed below.<br>Shoulder: rotator cuff repair | | | The Mitek Panalok Anchor with Orthocord are indicated for use in soft<br>tissue to bone fixation in association with adequate post- operative<br>immobilization as follows:. | | | Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator<br>cuff repair, capsule shift/ capsulo-labral reconstruction at anterior<br>glenoid rim site, shift/capsulo-labral reconstruction at the lesser<br>tuberosity of the humerus, , biceps tenodesis, acromio-clavicular<br>separation . | | | Elbow: Biceps tendon reattachment | | | Ankle: Achilles tendon repair/reconstruction, lateral stabilization,<br>medial stabilization at the medial talus site | | | Knee: Medial collateral ligament repair, lateral collateral ligament<br>repair, joint capsule closure to anterior proximal tibia, posterior oblique<br>ligament or joint capsule to tibia repair, extra capsular reconstruction /<br>ITB tenodesis, patellar ligament and tendon avulsion repairs | | | Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair,<br>rotator cuff repair, , capsule shift repair (glenoid rim) | {1}------------------------------------------------ Confidential {2}------------------------------------------------ Safety and Performance The determination of substantial equivalence for these devices were based on a detailed device descriptions, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria. > Based on the indications for use, technological characteristics, and comparison to predicate devices, the Panalok RC Quickanchor Plus (with ORTHOCORD), Panalok RC Quickanchor Plus Dual Suture (with ORTHOCORD) and Panalok Anchor (with ORTHOCORD) have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. Confidential {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DePuy Mitek, a Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767 NOV 2 2 2006 Re: K063273 > Trade/Device Name: Panalok RC QuickAnchor Plus with Orthocord, Panalok RC OuickAnchor Plus Dual Suture with Orthocord, and Panalok Anchor with Orthocord Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MAI Dated: October 27, 2006 Received: October 30, 2006 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. 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. {4}------------------------------------------------ Page 2 - Ms. Kristine Christo 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 af 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. 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, permite 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) 276-0120. 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 yours. Janbare Prelin Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K063273 Device Names: Panalok RC Quickanchor Plus, with Orthocord Panalok RC Quickanchor Plus Dual Suture with Orthocord Indications for Use: The Mitek Panalok RC QuickAnchor Plus with Orthooord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixstion and Mitts I allation RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone fo Shoulder: rotator cuff repair 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) Darlene Brens Page 1 of (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K062273 Confidential {6}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): Device Names: Panalok Anchor with Orthocord Indications for Use: The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:. Open Procedure Shoulder: Bankart repair, SLAP Iesion repair, capsule shift/ capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral repair, at the lesser tubero cats of the humerus, , biceps tenodesis, acromio-clavicular separation . Elbow: Biceps tendon reattachment Ankle: Achilles tendon repair/reconstruction, lateral stabilization at the medial talus site Knee: Medial collateral ligament repair, lateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITR tenodesis, patellar ligament and tendon avulsion repairs Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, , capsule shift repair (glenoid rim) Prescription Use 1 (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 Confidential 510(k) Premarket Notification: Special Panalok RC Quickanchor Plus With Orthocord Dual Suture Panalok RC Quickanchor Plus With Orthocord Panalok Anchor With Orthocord 51