FIXIT Threaded Anchor System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. S.B.M. SAS Science for Bio Materials Ms. Anne Cospin-Latapie Quality/Regulatory Affairs Manager ZI du Monge Lourdes, France 65100 November 30, 2017 Re: K170868 Trade/Device Name: FIXIT Threaded Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 19, 2017 Received: October 23, 2017 Dear Ms. Cospin-Latapie: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K170868 Device Name FIXIT Threaded Anchor System #### Indications for Use (Describe) The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ; Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair | Type of Use (Select one or both, as applicable) | | | | | |--------------------------------------------------|---------------------------------------------|--|--|--| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Science & Bio Materials (SBM). The letters S, B, and M are displayed in a horizontal line, with the B in blue and the other letters in gray. Below the letters is the text "Science & Bio Materials" in a smaller font. To the right of the letters are three right-pointing triangles, with the middle triangle having a blue gradient. ### 510(k) SUMMARY #### 1. SUBMITTER | S.B.M. SAS | |-------------------------------------| | SCIENCE FOR BIOMATERIALS | | ZI du Monge | | F 65100 LOURDES - FRANCE | | Registration Number: 3004549189 | | Phone: +33 (0)5 62 42 21 01 | | Fax: +33 (0)5 62 42 21 00 | | Contact Person: Anne COSPIN-LATAPIE | | e-mail : anne.cospin@sbm-fr.com | | Date prepared: November 29, 2017 | #### 2. DEVICE | Name of Device | FIXIT® Threaded Anchor System | |----------------------|---------------------------------------------------| | Common or Usual Name | Suture Anchor | | Classification Name | Fastener, fixation, biodegradable,<br>soft tissue | | Regulatory Class | II | | Product Code | MAI | ### 3. PREDICATE DEVICE Arthrex Bio-Composite Corkscrew manufactured by Arthrex, Inc., K082810 Referenced devices: K070673 Force Fiber® Black Co-braid Polyethylene non-absorbable Suture K063778 Force Fiber® Polyethylene non-absorbable Suture ### 4. DEVICE DESCRIPTION FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material. The implant is available in 2 different configurations: - · FIXIT®Knotless: supplied in a holder, {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo with the letters SBM in different colors. The letter B is in blue, while the letters S and M are in gray. Underneath the letters is the text "Science & Bio Materials" in a smaller font. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern. - FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures. The implant is supplied sterile, ready to use. ### 5. INDICATIONS FOR USE The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ; Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair. ## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE FIXIT® Threaded Anchor System is compared to Arthrex Bio-Composite Corkscrew (K082810) manufactured by Arthrex, Inc. The applicant device has the same intended use as the predicate device. The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Science & Bio Materials (SBM). The letters S and M are in gray, while the letter B is in blue. The words "Science & Bio Materials" are written in a smaller font size below the letters. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue grid pattern. | | FIXIT® Threaded<br>Anchor System | Arthrex Bio-Composite<br>Corkscrew | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | | Present submission | K082810 | | Intended use<br>(same) | Fixation of suture (soft tissue) to bone | | | | Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP<br>Lesion Repair; Biceps Tenodesis; Acromio-clavicular<br>Separation Repair; Deltoid Repair; Capsule Shift or<br>Capsulolabral Reconstruction; | | | | Ankle/Foot: Lateral Stabilization; Medial Stabilization;<br>Achilles Tendon Repair; Hallux Valgus Reconstruction;<br>Mid-foot Reconstruction, Metatarsal Ligament Repair/<br>Tendon Repair, Bumonectomy; | | | Indications for<br>use (same) | Knee: Anterior Cruciate Ligament Repair; Medial<br>Collateral Ligament Repair; Lateral Collateral Ligament<br>Repair; Patellar Tendon Repair ; Posterior Oblique<br>Ligament Repair; Iliotibial Band Tenodesis ; | | | | Wrist/Hand: Scapholunate Ligament Reconstruction;<br>Ulnar or Radial Collateral Ligament Reconstruction,<br>Radial Collateral Ligament Reconstruction. | | | | Elbow: Biceps Tendon Reattachment; Ulnar or Radial<br>Collateral Ligament Reconstruction; Tennis Elbow Repair<br>and Lateral Epicondylitis Repair, | | | Materials | TCP/PLDLA | TCP/PLLA or TCP/PLDLA | | | Ø 4,5mm x14,5 mm, 2<br>sutures | Ø 4,5mm x15 mm, 2<br>sutures | | Configuration/<br>dimensions | Ø 5,5mm x17,6 mm, 2<br>sutures | Ø 5,5mm x15 mm, 2 or 3<br>sutures | | | Ø 6,5mm x17,6 mm, 2<br>sutures | Ø 6,5mm x15 mm, 2 or 3<br>sutures | | Packaging | Anchor loaded with suture<br>on driver sealed in foil<br>pouch | Anchor loaded with suture<br>on driver sealed in plastic<br>tray with Tyvek pouch,<br>which is then sealed in a foil<br>pouch | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo with the letters S, B, and M. The letter B is in blue, while the letters S and M are in gray. Below the letters is the text "Science & Bio Materials". To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern. #### 4. PERFORMANCE DATA #### Non-clinical performance testing Non-clinical testing including biocompatibility, biological and mechanical performances was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits. #### Clinical performance testing: Clinical performance data was not included. #### 5. CONCLUSIONS The FIXIT® Threaded Anchor System is substantially equivalent to its predicate device Arthrex Bio-Composite Corkscrew (K082810). Verification and validation tests demonstrate that the FIXIT® Threaded Anchor System is as safe, as effective, and performs as safely and effectively as its predicate device.