GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

{0}------------------------------------------------ MAR 2 9 2010 RESPONSE-14 ACTIVITIES RESPONSE-10 K092493 (BACKED BY EXPERIENCE SINCE 1951) 150 9001 ISO 13485 Certified WHO - GMP compliant CE # Premarket Notification 510(k) Summary As required by Section 807.92 General Company Information as required by 807.92 (a) (a.l) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared: GPC Medical Limited G-3 Vikas Puri, New Delhi 110 018 Telephone Number: +91-11-45545151 Contact Person: Vikas Narang DATE: 3rd December 2009 (a.2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System Common Name: THE SMOOTH OR THREADED METALLIC BONE FIXATION FASTENERS ARE CATEGORISED UNDER THE 21CFR TITLE 888.3040 888.3030 Plate-Fixation-Bone . ) ' । THESE ALL DEVICES BELONG TO THE SAME REGULATION , i.e. 21 CFR TITLE 888.3030 & 888.3040 As these all devices belong to the same regulation and having same intended use-metallic bone plates and bone screws (fasteners), they have been bundled under the bundling of the devices. (a.3)An identification of the legally marketed device to which submitter claims equivalence PREDICATE DEVICE: AS PER THE DETAILS GIVEN BELOW NAME OF MANUFACTURER: MICROWARE PRECISION CO.LIMITED ADDRESS: No. 12, Keyuan, 2nd Rd. Situm district, Taichung City, 40763 Taiwan MICROWARE THE BONE PLATES AND BONE SCREW SYSTEM AND DHS/DCS PLATE SYSTEM 510k Number for M/s Microware Precision Co. Limited Image /page/0/Picture/24 description: The image shows a circular logo with the text "GPC Medical Ltd." surrounding an indiscernible image in the center. The logo also includes a phone number, "Tel. 011-2", and another number, "28546244", separated by stars. Above the logo, the text "K072562" is visible. PAGE 1 OF 32 CONFIDENTIAL {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters GPC in a white font. The letters are inside of a black outlined shape that resembles a rounded diamond. The logo is simple and easy to read. (BACKED BY EXPERIENCE SINCE 1930) ISO 9001 ISO 13485 Certified WHO - GMP compliant (a.4)A description of the device that is the subject of the premarket notification submission DEVICE NAME-COMMON NAME: Bone Fixation Plate and Screw Including SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER FIXATION BONE PLATES APPLIANCES FOR FIXATION-SKELETAL PINS ### DEVICES DECRIPTION: THE BONE PLATES.AND BONE SCREW SYSTEM AND DHS/DCS PLATE SYSTEM CONSIST OF NON-STERILE BONE PLANTE AND BONE SCREW IMPLANTS. THE PLATES ARE DEVICES WHICH ARE USED TO FASTEN THE BONES FOR THE PURPOSE OF FIXATION OF FRACTURED BONES. THE BONE PLATES CAN BE DISTINGUISHED IN TERMS OF THEIR FUNCTION, i.e. THE PLATE ON WHICH THIS IS TO BE FIXED. Generally there are following types of bone plates: - Dynamic Compression Type, - > Tubular Type - > Special (for particular bones) CONFIDENTIAL - > Mini fragment - > Used with Dynamic Hip screw and Used with Dynamic Condylar . Screw These bone plates are generally designed on the basis of the bone contour and anatomy. Image /page/1/Picture/17 description: The image shows a circular stamp with the text "GPC Medical Ltd." around the top half of the circle and "Tel. 011-28541648, Fax: 011-28546244" around the bottom half. Stars are used to separate the top and bottom text. The center of the stamp contains an unidentifiable image. PAGE 2 OF 32 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters GPC in a stylized font. The letters are white and are set against a black background. The logo is enclosed in a black diamond shape with a white border. ISO 9001 ISO 13485 Certified WHO - GMP compliant CE Following are further categories of bone plates: | S.<br>No. | Type | Subtype | |-----------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 01 | DCP | Small DCP, Narrow DCP, Lengthening<br>Narrow, Broad DCP, Lengthening Broad<br>Plates | | 02 | Tubular Plates | Quarter Tubular, Semi Tubular and One .<br>Third Tubular Plates | | 03 | Special Plates | L-Shaped, T-Shaped, Spoon, Lateral Tibial<br>Head Buttress, Condylar Buttress, Hook,<br>Cobra Head, Angled Plates for various<br>Osteotomy locations. Reconstructions<br>plates | | 04 | Mini Fragment | Straight, L-Shaped, T-Shaped, condylar<br>plates, reconstruction plates | | 05 | DHS/DCS | DHS Barrel Plate with various angles and in<br>short / large barrel length, DCS Plate | THESE DEVICE CAN BE MADE IN FOLLOWING MATERIALGRADES STAINLESS STEEL ALLOY in compliance to ASTM F 138, ASTM F 139 TITANIUM ALLOY in compliance to ASTM F 136 - > The GPC Bone Plates are divided mainly into Mini Fragment Plate system Small Fragment Plate System て Large Fragment Plate System The thickness of these plates varies from 1.0mm to 6.0mm The width of these plates varies from 3.0mm to 17mm The length of these plates varies from 15mm to 360mm The number of holes of these plates vary from 2 to 22 holes - The GPC Bone Screws are differentiated by the manner in which they are fastened on the bone, their function, their size and the type of bone they are intended to be used for. Four Types of Screws; Cortical (cortex) Screw Cancellous Screw Malleolar Screw Cannulated - ! : : : CONFIDENTIAL Image /page/2/Picture/10 description: The image shows a circular stamp with the text "GPC Medical Ltd." arranged around the top half of the circle. The bottom half of the circle contains the text "Tel: 911-28546244" and "Fax: 911-28546244". There are stars separating the text on the left and right sides of the circle. l'AGE 3 OF 32 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for GPC Medical Ltd. The logo consists of the letters "GPC" inside of a black hexagon. To the right of the logo is the text "GPC Medical Ltd." in a larger, bold font. The text is black and the background is white. (BACKED BY EXPERIENCE SINCE 1930) 1SO 9001 ISO 13485 Certified WHO - GMP compliant CE These screw variants can be provided with locking compression thread types as well as regular types. Type of Recess: Hexagonal Diameter Range: 1.5mm to 7.3mm Length Range: 6mm to 150mm - DHS / DCS Plate system consists of a DHS Plate or DCS Plate (Dynamic Hip Screw Type or Dynamic Compression Screw Type) This plate is fastened on femoral shaft using 4.5mm cortex screw (self tapping) and the barrel is fastened using DHS Screw having diameter ranging from 12.5mm to 14.0mm Barrel Length: 25mm or 38mm Barrel Angle: 95 degree, 135 degree, 140 degree, 145 degree, 145 degree and 150 degree Compression is achieved using 4.0mm Diameter Compression Screw. (a.5) A statement of the intended use of the device that is the subject of the premarket notification submission ### Intended Use: .) יליו . ﺑ ن ت : j . j : GPC Bone plates and bone screws are provided non-sterile. GPC bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges) GPC DHS / DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric and basilar neck fractures. CONFIDENTIAL Image /page/3/Picture/12 description: The image shows a circular seal with the text "GPC Medical Ltd." around the top half of the circle and "Tel. 011-43227699 Fax. 011-45545172" around the bottom half. Inside the circle is a logo with the letters "GPC" in a stylized font. The seal appears to be stamped, with some smudging and unevenness in the ink. PAGE 4 OF 32 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "GPC" in a stylized font. The letters are white and are set against a black background. The logo is enclosed in a black diamond shape with a white border. The logo appears to be a trademark or brand identifier. GPC Medical Ltd. ISO 9001 ISO 13485 Certified WHO - GMP compliant (b.1) (1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence; GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System have been tested for the following non-clinical tests which have been performed to assess the performance of the devices according to the standards applied for conformance to the requirements. Therefore GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System are safe and effective for the intended use. The devices have been thoroughly tested through external laboratory as well in-house inspections for the specifications. Verification of compliance with the following mandatory and voluntary standards has been made. GPC Metallic Bone Plates: Tested as per ASTM F 382 (US FDA Recognized Standards vide recognition number 11-214 GPC Metallic Angled Orthopaedic Fracture Fixation Devices: Tested as per ASTM F 384. GPC Medical Smooth or Threaded Metallic Bone Fixation Fasteners: Tested as per ASTM F 543 (US FDA Recognized Standards vide recognition number: 11-210 ### Material Standards: ASTM F 136: Specifications for wrought Titanium 6AI4V ELI Alloy UNS R 56401 for surgical implants ASTM F 138: Specifications for wrought 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implant ASTM F 139 ### (b.3) Conclusion The summary above shows that there are no new questions of safety and effectiveness for the GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System as compared to the predicate device. The performance and usability testing indicate that the GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System is substantially equivalent to the predicate device Microware the bone plates and bone screw system and DHS/DCS plate system. CONFIDENTIAL Image /page/4/Picture/16 description: The image shows a circular stamp with the text "GPC Medical Ltd." around the top half of the circle. The bottom half of the circle contains the text "Tel: 011-2681 Fax: 2681". There are stars on either side of the top text. PAGE 32 OF 32 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of a bird or eagle, with its wings spread. The image is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN - 4 2010 GPC Medical Limited % Mr. Vikas Narang Director - Exports M-Block, DDA LSC. Vikas Puri, New Delhi - 110018 (INDIA) Re: K092493 Trade Name: GPC Bone Plates and Bone Screw & GPC DHS/DCS Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: HRS, KTT; HWC Dated: March 12, 2010 Received: March 17, 2010 Dear Mr. Narang: This letter corrects our substantially equivalent letter of March 29, 2010. 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 (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. You must {6}------------------------------------------------ Page 2 - Mr. Vikas Narang 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. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark A. Wilkerson Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K o92493 Device Name: GPC BONE PLATES AND BONE SCREWS Indications For Use: GPC BONE PLATES AND BONE SCREWS ARE PROVIDED NON-STERILE. GPC BONE PLATES AND SCREWS ARE INTENDED TO TREAT FRACTURES OF VARIOUS BONES, INCLUDING THE CLAVICLE, PELVIS, SCAPULA, LONG BONES(HUMERUS, RADIUS, ULNA, FEMUR, TIBIA AND FIBULA), AND SMALL BONES-LIKE METALCARPALS, METATARSALS AND PHALANGES. > GPC DHS/DCS PLATE SYSTEM IS PROVIDED NON-STERILE. THE GPC DHS/DCS PLAT SYSTEM IS INTENDED FOR USE IN FIXATION OF FRACTURES OF THE PROXIMAL FEMUR. THE GPC DHS/DCS PLATE SYSTEM IS INDICATED FOR USE IN TROCHANTERIC, PERTROCHANTERIC, INTERTROCHANTERIC AND BASILAR NECK FRACTURE Prescription Use (Part 21 CFR 801 Subpart D) . n • i . AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) ·4 亿元 (PLEASE DO NOT WRITE BELOW THIS LIÎNE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Barbara Brenno G.M.M (Division Sig. or oth ivision Sign-O Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number k092493 Page 1 of