Extremity Medical Suture Anchor

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2015 Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054 Re: K150166 Trade/Device Name: Extremity Medical 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: January 22, 2015 Received: January 26, 2015 Dear Mr. Smekal: 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ Page 2 - Mr. Brian Smekal 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 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 vours. # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic 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) K150166 Device Name Extremity Medical Suture Anchor #### Indications for Use (Describe) The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ # Special 510(k) Summary of Safety and Effectiveness: # Suture Anchor | Submitter: | Extremity Medical, LLC.<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Brian Smekal, MS, RAC<br>Director, Regulatory Affairs<br>Phone: (973) 588-8988<br>Email: bsmekal@extremitymedical.com | | Date Prepared | January 22, 2015 | | Trade Name | Extremity Medical Suture Anchor | | Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 | | Product Code | MBI (fastener, fixation, nondegradable, soft tissue) | | Predicate Devices | K083151 - Suture Anchor (Extremity Medical) | | Device Description | The Extremity Medical Suture Anchor is an implantable device manufactured<br>from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is<br>preloaded with two or three sutures depending on the size of the anchor. The<br>suture material is Size #2 Teleflex Force Fiber. The device is recommended to be<br>used for the repair of soft tissue to bone. The suture anchor and sutures are<br>assembled to an inserter which is used to screw the anchor into bone. The<br>product is provided pre-packaged and sterile via EtO sterilization. | | Indications for use | The Extremity Medical Suture Anchor is intended for the fixation of suture<br>and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and<br>elbow in the following procedures:<br><br>Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular<br>Shift of Capsulolabral Reconstruction.<br><br>Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament<br>Repair/Tendon Repair, Bunionectomy.<br><br>Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis.<br><br>Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral<br>LigamentReconstruction | | | Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial<br>Collateral Ligament Reconstruction. | | Statement of<br>Technological<br>Comparison | The modified Suture Anchor and predicate devices are equivalent in terms of<br>indications for use, design, and material mechanical properties. | | Non-clinical Testing | Bench testing, including pull-out strength was performed and compared to the<br>predicate device. | | Clinical Testing | No clinical testing was performed. | | Conclusion | The modified Suture Anchor is substantially equivalent to its predicate device.<br>This conclusion is based upon indications for use, materials, design, test data and<br>principles of operation. | {4}------------------------------------------------