SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the words "ross CREEK medical" in a bold, sans-serif font. The words "ross CREEK" are stacked on top of the word "medical". The word "medical" is italicized and slightly smaller than the words above it. The text is black and the background is white. #### 510(k) for the Spin-Loc Suture Anchor System K090530 April 16, 2009 # 510(k) Summary (per 21CFR807.92) | General Company Information | | | | |-------------------------------------------------------------------------------------------------|--------------------------------------------------------|--|---------------| | Name: | Ross Creek Medical, Inc. | | | | Contact: | Michael Kolber | | | | | Vice President, Regulatory Affairs | | | | Address: | 16417 Peacock Lane | | | | | Los Gatos, CA 95032 | | | | Telephone: | 408-505-6626 | | | | Fax: | 408-358-2381 | | | | Date Prepared: | April 16, 2009 | | | | General Device Information | | | | | Product Name: | Spin-Loc Suture Anchor System | | | | Common Name: | Suture Anchor | | | | Classification: | Screw, fastener, fixation, non-degradable, soft tissue | | | | | 21 CFR 888.3040 | | | | Device Class: | Product Code: MBI | | | | Product Code: | Class: II | | | | Predicate Devices | | | | | Manufacturer | Device Name | | 510(k) Number | | Arthrex | PushLock | | K063479 | | Mitek | Versalok | | K063478 | | Teleflex Medical | Force Fiber | | K063778 | | Description | | | | | The Spin-Loc Suture Anchor System consists of a PEEK polymer and stainless steel or cobalt | | | | | chromium alloy suture anchor loaded on an insertion handle. The Spin-Loc anchor is | | | | | designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to adjust | | | | | the tension on the tissue after insertion of the anchor into bone. The Spin-Loc Suture Anchor | | | | | System will be validated to a SAL of 10-6 using ethylene oxide. The ethylene oxide residuals | | | | | will be tested according to ISO10993-7. | | | | | Intended Use (Indications) | | | | | The Spin-Loc Suture Anchor System is intended to be used for soft tissue fixation to bone in | | | | | the shoulder, foot and ankle, knee, and elbow. The anchor is intended for use in the following | | | | | procedures: | | | | | Shoulder | Knee | | | | ▪ Rotator Cuff Repair | ▪ Medial Collateral Ligament Repair | | | - Bankart Repair 미 - SLAP Lesion Repair - Biceps Tenodesis - 제 Acromio-Clavicular Separation Repair - 요 Deltoid Repair - Capsular Shift/Capsulolabral Reconstruction. I - M Lateral Collateral Ligament Repair - 트 Patellar Tendon Repair - . Posterior Oblique Ligament Repair - . Illiotibial Band Tenodesis {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the words "ross creek" in large, bold, black letters on the top line. Below that, the word "medical" is written in a smaller, italicized font, also in black. The words appear to be a logo or heading for a medical practice or facility. 510(k) for the Spin-Loc Suture Anchor System K090530 April 16, 2009 - Foot and Ankle Elbow · Lateral Stabilization · Biceps Tendon Reattachment Medial Stabilization Achilles Tendon Repair · Hallux Valgus Reconstruction Midfoot Reconstruction . . Metatarsal Ligament Repair Substantial Equivalence This submission supports the position that the Ross Creek Spin-Loc Suture Anchor System is substantially equivalent to a number of previously cleared devices, including the Arthrex PushLock [510(k) Number K063479], the Mitek Versalok [(510(k) K063478) and the Teleflex Medical Force Fiber [K063778]. The 510(k) notice contains summaries of in vitro studies that were conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996). The data presented demonstrate that the anchor pullout for the Ross Creek Spin-Loc Suture Anchor System compares favorably with the predicate devices. The failure modes observed for the Spin-Loc Suture Anchor were the same as those of the predicate devices. The single patient use components of the bone anchor system are provided sterile. #### Conclusions Ross Creek Medical. Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and do not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics. and comparison to predicated devices, the Spin-Loc Suture Anchor System has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal lines representing the feathers. MAY 20 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ross Creek Medical Inc. c/o Mr. Michael Kolber 14734 LA Rinconada Drive Los Gatos, California 95032 Re: K090530 Trade/Device Name: Spin-Loc Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 16 2009 Received: April 21, 2009 Dear Mr. Kolber: 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. 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 {3}------------------------------------------------ ### Page 2 – Mr. Michael Kolber 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, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, for Pete Des O.f Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "ross creek" in large, bold, black letters on the top line. Below that, the word "medical" is written in a smaller, italicized font, also in black. The text appears to have a slightly distressed or textured effect, giving it a somewhat vintage or rugged look. 510(k) for the Spin-Loc Suture Anchor System K090530 April 16, 2009 # Indications for Use . 510(k) Number (if known): K090530 Device Name: Spin-Loc Suture Anchor System Indications for Use: The Ross Creek Spin-Loc Suture Anchor System is intended to be used for soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is intended for use in the following procedures: #### Shoulder - Rotator Cuff Repair . - Bankart Repair . - I SLAP Lesion Repair - . Biceps Tenodesis - Acromio-Clavicular Separation Repair I - Deltoid Repair 제 - Capsular Shift/Capsulolabral Reconstruction ■ #### Foot and Ankle - " Lateral Stabilization - . Medial Stabilization - · Achilles Tendon Repair - · Hallux Valgus Reconstruction - " Midfoot Reconstruction - · Metatarsal Ligament Repair #### Knee - Medial Collateral Ligament Repair . - · Lateral Collateral Ligament Repair - · Patellar Tendon Repair - . Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis #### Elbow - Biceps Tendon Reattachment li The Ross Creek Spin-Loc Suture Anchor System is intended for single-use only. Prescription Use *X* (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Anita Le PHS (Division Sign-off) loss of Suries Device of CDRH, Office of Device Evaluation (ODE) and Restorative Devices 510(k) Number K090530