SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM

{0}------------------------------------------------ K031609 Page 1 of 1 ## Attachment VI Summary of Safety and Effectiveness Information 510(k) Summary | Sponsor: | Swiss Orthopedic Solutions Inc.<br>26 Turnstone Way<br>Downingtown, PA 19335<br>Phone: (610) 524-8142<br><br>Contact: Bob Bennett | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Bone Plate and Bone Screw | | Classification Name: | Single/multiple component metallic bone fixation appliance and accessories | | Device Classification: | Class II, 21 CFR 888.3030 and 888.3040 | | Name of Device: | Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set | | Predicate Device: | Synthes (USA) Dynamic Locking Compression (DCL) System, also known as<br>the Locking Compression Plate Set. | | Description of Device: | The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and<br>screw system. The available plate selection consists of straight, reconstruction,<br>tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm<br>locking screws. The plates in the system can also accept standard spherical<br>2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate<br>features a hole that is fully threaded, allowing the use of any screw in a variety of<br>positions. The system is available in either stainless steel or titanium. | | Indications: | The Swiss Orthopedic Solutions Inc. Small Fragment Locking Plate Set is a plate<br>and screw system, intended to treat fractures osteotomies and non-unions of<br>various bones, including but not limited to, the radius, ulna, proximal and distal<br>tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic<br>bone. | | Substantial<br>Equivalence: | The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is<br>considered substantially equivalent to the Synthes (USA) Dynamic Compression<br>Locking (DCL) System, also known as the Locking Compression Plate Set. | | Safety and<br>Effectiveness: | The plates which are included in this set, are manufactured of from<br>biocompatible materials commonly used in the orthopedic industry. The plates<br>were shown to exhibit strength characteristics comparable to the predicate<br>devices. No new indications have been introduced with these devices.<br>Therefore, the Swiss Orthopedic Solutions Inc. Small Fragment Locking Plate set<br>is considered to be a safe and effective means of fracture fixation. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or a bird in flight, rendered in black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN = 9 2003 Mr. Bob Bennett Swiss Orthopedic Solutions, Inc. 26 Turnstone Way Downingtown, PA 19335 Re: K031609 Trade/Device Name: Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, KTT Dated: May 20, 2003 Received: May 27, 2003 Dear Mr Bennett: 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 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. {2}------------------------------------------------ Page 2 - Mr. Bob Bennett 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Miriam C. Provost Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page: 1 of 1 510(k) Number (if known): k031609 Device Name: Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set Indications for Use: The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone. ## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use Miriam C. Provost (Division Sign-Off) Division of Comeral, Restorative and Neurological Devices 510(k) Number K 031609 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·