QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY

{0}------------------------------------------------ (fg 1 of 3) 510(k) Summary Quattro™ Link Knotless Anchor # 510(k) Summary OCT 31 2012 Cayenne Medical, Inc. Quattro™ Link Knotless Anchor # ADMINISTRATIVE INFORMATION 510(k) Number # K122314 Manufacturer Name: Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (888) 334-4079 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (888) 334-4079 kshahriari@cayennemedical.com Kereshmeh Shahriari Official Contact: 510(k) Summary Preparation Date July 31, 2012 DEVICE NAME Product Code MBI Classification Names: Trade/Proprietary Name: Quattro™ Link Knotless Anchor Fastener, Fixation, Nondegradable, Soft Tissue Suture Anchor Common Name: # DEVICE CLASSIFICATION FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code is MBI, Fastener, Fixation, Nondegradable, Soft Tissue. These devices are reviewed by the Orthopedic Joint Devices Branch. {1}------------------------------------------------ 510(k) Summary # INTENDED USE The Cayenne Medical, Inc. Quattro Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: ### Shoulder - Capsular stabilization - o Bankart repair - o Anterior shoulder instability - o SLAP lesion repairs - o Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs t - Deltoid repairs - -Rotator cuff repairs - Bicep tenodesis | ## Elbow, Wrist, and Hand - ו Biceps tendon reattachment - Ulnar or radial collateral ligament reconstruction | - -Lateral epicondylitis repair ### Knee - Extra-capsular repairs । - o Medial collateral ligament - o Lateral collateral ligament - o Posterior oblique ligament - । Patellar realignment and tendon repairs - o Vastus medials obliquous advancement - Illiotibial band tenodesis । #### Foot and Ankle - Hallux valgus repairs । - -Medial or Lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions -। - Midfoot reconstructions l - Metatarsal ligament/tendon repairs/reconstructions 1 - l Bunionectomy ## DEVICE DESCRIPTION The Quattro™ Link Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in shoulder, elbow, wrist, hand, knee, foot, and ankle procedures. The anchor is mounted on an inserter. The Quattro Link Knotless {2}------------------------------------------------ K122314 (pg. 3 of 3) ## 510(k) Summary Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK only). The all PEEK anchor is offered in three different sizes, 2.9mm, 4.5mm. The PEEK and titanium alloy tip anchor is offered in one size, 4.5mm. # NON-CLINICAL TESTING Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included. Mechanical testing was performed on the Quattro Link Knotless Anchor and Inserter. It was shown that maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices. Dimensional analysis was performed on the Quattro Link Knotless Anchor and Inserter. Product dimensional analysis met the components and product specifications. # EQUIVALENCE TO MARKETED PRODUCT Cavenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Quattro Link Knotless Anchor is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Cayenne Medical Quattro Link (CuffLink ) Knotless Anchor (K112876), Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and Smith & Nephew Bioraptor Suture Anchor (K093428). The data included in this submission demonstrates substantial equivalence to the predicate devices listed above. The subject device Quattro Link Knotless Anchor with Inserter has the same intended use, materials, manufacturing processes, packaging, sterilization method, and shelf life as the Cayenne Medical Quattro Link (CuffLink) Knotless Anchor (K112876). The subject device Quattro Link Knotless Anchor with Inserter has identical design and technology to the Cayenne Medical Quattro Link (CuffLink) Knotless Anchor (K112876). Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Cayenne Medical, Incorporated % Ms. Keresheh Shahriari 16597 N. 92nd Street, Suite 101 Senior Director Regulatory Affairs and Quality Assurance Scottsdale, Arizona 85260 OCT 3 1 2012 Re: K122314 Trade/Device Name: Quattro™ Link Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 16, 2012 Received: October 18, 2012 Dear Ms. Shahriari: 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 10 use stared in the Merceans)77, the enactment date of the Medical Device Amendments, or to connineroo pror to tria) 20, 2012, 11:31 in accordance with the provisions of the Federal Food, DNG and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometic . Its ( . 10) leat the device, subject to the general controls provisions of the Act. The r ou may, moreleve, mains 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 adunction. Ticasonote. ODAC acce as a second as a secure 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 If your device to additional controls. Existing major regulations affecting your device can be may of subject to additions, 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 r teaso be action and a determination that your device complies with other requirements of the Act that I Driver Intacted and regulations administered by other Federal agencies. You must or any 1 occar Lances and 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 {4}------------------------------------------------ Page 2 - Ms. Kereshmeh Shahriari 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/CDRH/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/Resourcesfor You/Industry/default.htm. Sincerely yours, For Pt Lin Nu Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Quattro™ Link Knotless Anchor # Indications for Use 510(k) Number (if known): _K122314 Device Name: Quattro™ Link Knotless Anchor Indications for Use: The Cayenne Medical, Inc. Quattro™ Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: #### Shoulder - Capsular stabilization - 0 Bankart repair - o Anterior shoulder instability - o SLAP lesion repairs - o Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - - Rotator cuff repairs - - Bicep tenodesis ﺳﮯ ## Elbow, Wrist, and Hand. - Biceps tendon reattachment - - Ulnar or radial collateral ligament reconstruction - - Lateral epicondylitis repair - #### Knee - Extra-capsular repairs । - 0 Medial collateral ligament - o Lateral collateral ligament - Posterior oblique ligament o - Patellar realignment and tendon repairs - - Vastus medials obliquous advancement o - Illiotibial band tenodesis - #### Foot and Ankle - Hallux valgus repairs । - Medial or Lateral instability repairs/reconstructions - - Achilles tendon repairs/reconstructions {6}------------------------------------------------ K122314 (pg. 2 of 2) # 510(k) Premarket Notification - Midfoot reconstructions - Metatarsal ligament/tendon repairs/reconstructions . I - Bunionectomy - Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number k122314