TRIMED STERILE PRODUCT

{0}------------------------------------------------ K091156 (pg. 1 of 2) JUL 1 5 2009 # 510(K) Summary of Safety and Effectiveness TRIMED STERILE PRODUCT Submitted By: Registration #: Prepared By/Contact Person: Proprietary Name: Classification: 510(K)'s Being Modified: TriMed, Inc. 25864 Tournament Road, Ste. A Valencia, CA 91355 (800)633-7221 2031009 Kelli Anderson Phone: (661)312-7150 Fax: (661)254-8485 TriMed Sterile Product Class II: Screw, Fixation, Bone HWC - Section 888,3040 Class II: Plate, Fixation, Bone HRS - Section 888.3030 Class II: Pin, Fixation, Smooth, Metallic NDL - Section 888.3040 Class II: Nail, Fixation, Bone JDS - Section 888.3030 Class II: Fastener, Fixation, Nondegradable, Soft Tissue MBI - Section 888.3040 Class II: Pin, Fixation, Smooth HTY - Section 888.3040 K951302 - TriMed, Inc. (Formerly MEDPAC) Small Fragment Plates & Screws K951303 - TriMed, Inc. (Formerly MEDPAC) SFC K010545 - TriMed, Inc. TBW 1 of 2 {1}------------------------------------------------ ### 510(K)'s Being Modified (cont'd): K040112 - TriMed, Inc. Bearing & Volar Bearing Plate K043263 - TriMed, Inc. Osteotomy Plate K060041 - TriMed, Inc. Bone Plates K081348 - TriMed, Inc. Tenodesis Cross Screw, Interference Screw, Suture Bead #### IV. Indications For Use: The indications for use for each product cleared under 510(K) remains the same. The only difference in the product is that it will now be available sterile. #### II. Device Description: The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6. Cuih Kelli Anderson, M.S., RAC Regulatory Affairs Specialist {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an eagle-like emblem with three horizontal bars extending from its body. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 TriMed, Inc. % OrthoCompliance Ms. Kelli Anderson 28337 Maitland Lane Saugus, California 91350 JUL 1 5 2009 Re: K091156 Trade/Device Name: Trimed Sterile Product Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, JDS, HWC, NDL, HTY, MBI Dated: June 17, 2009 Received: June 19, 2009 Dear Ms. Anderson: 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 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 (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. {3}------------------------------------------------ Page 2- Ms. Kelli Anderson 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Barbara Brienup Mark N. Melkei Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K091156 Device Name:___Small Fragment Plates and Screws Used as an aid to the healing of volar rim fractures of the distal radius. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Souther for MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 Page 1 of {5}------------------------------------------------ 510(k) Number (if known): K091156 #### Device Name:__________________________________________________________________________________________________________________________________________________________________ Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically: - Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone. - An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. - A combination of the above Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Saktu dm mxu (Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices 510(k) Number K091156 Page 1 of 1 {6}------------------------------------------------ 510(k) Number (if known): __ K091156 Device Name: _ Tension Band Wire Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sousta (Division Sign Off) Jo MKM Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 Page 1 of 1 {7}------------------------------------------------ 510(k) Number (if known): K091156 Device Name: TriMed Bearing Plate: TriMed Volar Bearing Plate 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sauta for mxn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 Page 1 of {8}------------------------------------------------ 510(k) Number (if known): K091156 Device Name:__________________________________________________________________________________________________________________________________________________________________ The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) Page 1 of (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ooutu (Division Sign-Off) for mxn Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 {9}------------------------------------------------ 510(k) Number (if known): K091156 ### Device Name:_ TriMed Bone Plates The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ometu (Division Sign-Off) of mkm Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 Page 1 of {10}------------------------------------------------ 510(k) Number (if known): K091156 Device Name: TriMed Tenodesis Cross Screw and Interference Screw Indications For Use: The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include: Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle. Prescription Use × (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) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of Sputu for mxm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091156 {11}------------------------------------------------ 510(k) Number (if known): K091156 Device Name: TriMed Suture Bead Indications For Use: The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment. The TriMed Suture Bead is not indicated for use within intra-articular sites. 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) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Onetia for MXM vision Sig Division of Surgical, Orthopedic and Restorative Devices 510(k) Number