SUTUREFIX Curved Suture Anchor

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing ribbon-like element extending from the bottom profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 7, 2016 Smith and Nephew, Inc. Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810 Re: K163034 Trade/Device Name: SUTUREFIX Curved Suture 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 28, 2016 Received: October 31, 2016 Dear Ms. Keefe: 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 and 8091); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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. # Mark N. Melkerson -S Mark N. Melkerson Division Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K163034 #### Device Name SUTUREFIX Curved Suture Anchor Indications for Use (Describe) The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Rotator cuff tear repairs - Bicepts tenodesis Type of Use (Select one or both, as applicable) | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"></span> <span style="font-size: 20px;">☑</span> | <span style="text-decoration: underline;"></span> <span style="font-size: 20px;">☐</span> | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ T 978-749-1000 978-749-1443 www.smith-nephew.com Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew" in a combination of gray and orange colors. The words "We are" are in gray, while "smith&nephew" is in orange. # 510(k) Summary ### Prepared: 29 November 2016 | Submitter Information | Contact Information | |---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Smith & Nephew, Inc.<br>Endoscopy Division<br>150 Minuteman Road<br>Andover, MA 01810 | Anne-Marie Keefe<br>Senior Regulatory Affairs Specialist<br>Phone: (508) 261-3713<br>Fax: (978) 749-1443 | | Device Name & Classification | | |------------------------------|------------------------------------------------| | Proprietary Name | SUTUREFIX Curved Suture Anchor | | Common Name | Soft Tissue Fixation Device | | Classification Name | Fastener, fixation, nondegradable, soft tissue | | Classification Regulation | 21 CFR 888.3040 | | Class | II | | Product Code(s) | MBI | | Panel | Orthopedic | ## Legally Marketed Predicate Devices The Smith & Nephew SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: | Description | Submission<br>Number | Clearance Date | |--------------------------------|----------------------|-------------------| | SUTUREFIX All Suture Anchor | K122059 | March 18, 2013 | | BIORAPTOR 2.3 PK Suture Anchor | K102660 | December 13, 2010 | ## Device Description The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators. {4}------------------------------------------------ #### Intended Use The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder - · Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Rotator cuff tear repairs - Bicepts tenodesis #### Technological Characteristics The Smith & Nephew SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew SUTUREFIX Ultra Suture Anchor (K122059), and the BIORAPTOR 2.3 PK Suture Anchor (K102660), and raises no new issues of safety and efficacy. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate SUTUREFIX Ultra Suture Anchor use the identical component materials, and all-suture based implant configurations. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate BIORAPTOR 2.3 PK Suture Anchor share the same curved, anchor delivery system. #### Summary Performance Data Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. Performance data demonstrates that the SUTUREFIX Curved Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices. #### Substantial Equivalence Information The substantial equivalence of the SUTUREFIX Curved Suture Anchor is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the SUTUREFIX Curved Suture Anchor is substantially equivalent to its predicates.