GENEROS SB SMALL BONE DISTRACTION IMPLANT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', 'o', '5', '1', '1', '6', and '2'. The characters are written in a bold, handwritten style. Image /page/0/Picture/1 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye graphic on the left, followed by the company name in a blocky, sans-serif font. Below the name, in smaller font, is the tagline "the osteoplastic surgery company". 510(k) Premarket Notification JUL 1 9 2005 GenerOs SB Small Bone Distraction Implant ## Section 1.3 #### Summary of Safety and Effectiveness ## REGULATORY AUTHORITY Safe Medical Devices Act of 1990, 21 CFR 807.92 ## COMPANY NAME/CONTACT Terry Knapp, MD OrthoNetx, Inc. 1000 S. McCaslin Blvd, Suite 300 Superior, CO 80027 Voice: 303.494.1681 x 301 FAX: 303.494.1714 #### NAME OF DEVICE | Trade Name: | GenerOs™ SB Small Bone Distraction Implant | | | |---------------------|-------------------------------------------------------------------------------|--|--| | Common Name: | Internal Bone Plate Distractor | | | | Common Description: | Single/Multiple component metallic bone fixation<br>appliance and accessories | | | #### Classification Names: | Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class | |----------------------|-----------------|--------------------------------------------------------------------------------|-----------------| | 21 CFR<br>888.3030 | KTT | Appliance, fixation,<br>nail/blade/plate<br>combination, multiple<br>component | II | | 21 CFR<br>888.3030 | HRS | Plate, Fixation, Bone | II | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye-like symbol on the left, followed by the word "OrthoNet" in a modern, sans-serif font. Below "OrthoNet," the word "Incorporated" is written in a smaller font, and below that is the tagline "the osteoplastic surgery company". ## DEVICE DESCRIPTION GenerOs SB is an implantable device made of surgical grade stainless steel for deficiencies of small bones of the extremities. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. The activation pin and the drive shaft are articulated using an internal gear. The device has a fixation plates on the activation and sliding block, and if not used for fixation of the device, may be easily removed. Activation of the drive shaft occurs through a transcutaneous pin. which is removed once the distraction phase is complete. The GenerOs SB implant is removed after distraction and consolidation are complete. The GenerOs SB includes reusable instruments such as activation, insertion / removal tools and other surgical instruments. GenerOs SB is a single-use device, sold non-sterile, and requires sterilization prior to use. It is. Sterilization instructions are included in the labeling. ## INDICATION FOR USE STATEMENT The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to: - Congenital deficiencies of the bones of the forearms, wrists, ankles, hands . and feet; - . Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet: - Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due . to tumor resection. Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface. ## PREDICATE DEVICES - GenerOs Bone Generator; OrthoNetx, Inc. (formerly Inter-Os Technologies) . (#K993869) - Limb Lengthener; OrthoNetx, Inc, (#K031875) ● - Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) . - Lorenz Small Fragment System (#K992961); Walter Lorenz Surgical, Inc. - LCP Modular Foot Plates; Synthes (USA), (#K050110) {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye graphic on the left, followed by the word "OrthoNet" in a bold, sans-serif font. Below "OrthoNet" is the text "Incorporated X." and the tagline "the osteoplastic surgery company". # SUBSTANTIAL EQUIVALENCE COMPARISON The GenerOs SB is identical in features and technology to the GenerOs CF Craniofacial Bone Generator (#K993869); the only difference is the indication for use. The features and indications for use are compared to OrthoNetx' Limb Lengthener (#K031875). Indications for use are compared to Arthrex Small Fragment Plates and Screws by Arthrex, Inc., (#K040907); Lorenz Small Fragment System (#K992961) by Walter Lorenz Surgical, Inc. and LCP Modular Foot Plates by Synthes (USA), (#K050110). The GenerOs SB is substantially equivalent to predicate devices based on the descriptive characteristics, similar intended use, and same principle operation of distraction osteogenesis. #### PERFORMANCE Performance of the GenerOs SB has been substantiated by biocompatibility, sterilization, packaging validation, and mechanical tests in conformance to standard testing quidelines for bone plate implant devices. #### CONCLUSION Based on the design, materials, function, intended use, the GenerOs SB is substantially equivalent to the devices currently cleared under the Federal Food, Drug and Cosmetic Act. The GenerOs SB Distraction Implant raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, iustifying 510(k) clearance for the GenerOs SB Distraction Implant. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: a symbol and text. The symbol is a stylized representation of a human figure with three heads, suggesting a focus on people and well-being. The text is arranged in a circular pattern around the symbol, spelling out "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 19 2005 Terry Knapp, M.D. CEO OrthoNetX, Inc. 1000 S. McCaslin Blvd. Suite 300 Superior, Colorado 80027 i Re: K051162 Trade/Device Name: GenerOs™ SB Small Bone Distraction Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, HRS Dated: May 4, 2005 Received: May 5, 2005 Dear Dr. Knapp: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Dr. Knapp This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nother in the r DAY midning of backand of ... 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 If you desire specific advice for your accept (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Compilance in (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Eun A. Kim Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ OrthoNet Incorporated *"the osteoplastic surgery company"* | Section | 1.2 | |---------|-----| |---------|-----| ## Indications for Use Statement 510(k) Number: Device Name: GenerOs™ SB Small Bone Distraction Implant Indications for Use: The GenerOs SB is an implantable device for distraction osteogenesis techniques in t the GenerOs SB is an implantable downed to treat conditions where the small bone of the extremities are deficient. The types of deformities that fall into this ategory include, but are not limited to: - Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet: - and leet, Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet; - and leet, to tumor resection. Each GenerOs SB is intended for single use only. The device is to be removed after . Lach OcherOS OD is intonuba so ere complete. It is to be used with other distraction and bone stablization are semplotes, such as bone screws for fixation to the commercially-available accessery do heef on the bone with bone with bone with bone cement. The bone surface. The device is not intended to be fixed to the word on the . However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize the GenerOs SB on a curved surface. | Prescription Use | XX | or | Over-The-Counter Use | |----------------------|----|----|----------------------| | (Per 21 CFR 801.109) | | | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Confidential | K051162 1-2 | |--------------|-------------| |--------------|-------------|