WMT MODULAR ULNAR HEAD IMPLANT

{0}------------------------------------------------ Q20274 page 1 of 3 Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name, the address "5677 Airline Road, Arlington, TN 38002" and the phone number "901-867-9971" are printed. FEB 2 2 2002 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the WMT MODULAR ULNAR HEAD. | Submitted By: | Wright Medical Technology, Inc. | |-------------------------------------|---------------------------------------------------------------| | Date: | January 25, 2002 | | Contact Person: | Ehab M. Esmail<br>Manager, Regulatory Affairs | | Proprietary Name: | WMT MODULAR ULNAR HEAD | | Common Name: | ULNAR HEAD IMPLANT | | Classification Name and Reference: | 21 CFR 888.3810 Prosthesis, WRIST, HEMI-,<br>ULNAR - Class II | | Device Product Code and Panel Code: | Orthopedics/87/KXE | ### DEVICE INFORMATION ### A. INTENDED USE The WMT Modular Ulnar Head Implant is indicated for the following indications : - Replacement of the distal ulnar head for disorders of the distal radioulnar joint . in rheumatoid, degenerative and post-traumatic arthritis presenting with the following findings: - -pain and weakness of the wrist joint not improved by nonoperative treatment; - -instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint; - -failed ulnar head resection; e.g. Darrach resection - Primary replacement after fracture of the ulnar head or neck. . - . Revision following failed ulnar head arthroplasty. Image /page/0/Picture/16 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, with a line underneath. Image /page/0/Picture/17 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The image is simple and does not contain any other objects or details. {1}------------------------------------------------ WMT Modular Ulnar Head Implant 510(K) SUMMARY Page 2 of 3 020274 page 2 of 3 #### B. DEVICE DESCRIPTION The design features of the WMT Modular Ulnar Head Implant (Figure 1) is substantially equivalent to the Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT -- 510(k): K010786). Image /page/1/Figure/5 description: The image shows two different types of medical technology, Wright Medical Technology and AVANTA. Each technology has a standard stem, a head, and a revision stem. The Wright Medical Technology components are shown in black, while the AVANTA components are shown in gray. The image provides a visual comparison of the components of the two technologies. Figure 1 - Comparison Between WMT and Avanta uHead™ modular ulnar head implants The WMT Modular Ulnar Head Implant was designed as a more anatomic alternative to the previously submitted and cleared Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT – 510(k): K010786) that utilizes axisymmetric head and stem components. The anatomy of the distal ulna is not axisymmetric, but rather consists of a head that is offset medial-lateral and dorsal-volar from the ulnar canal. Cadaveric analysis has shown that there is no correlation between head and stem location, thus a system where the head is offset relative to the stem is required to replicate normal anatomy and thus, joint kinematics. The WMT Modular Ulnar Head is manufactured from cobalt chrome (ASTM F799 or F1537). The triangulated head will have a highly polished exterior surface across the articulating arc and distal surface, and will have a plasma sprayed textured surface laterally for tissue adhesion. The heads will be available in sizes ranging from 16mm to 22mm in diameter, 8mm to 11mm in height, and 1.5mm to 3mm in offset. The WMT Modular Ulnar Head Implant will contain suture holes for attaching soft tissues and a locking taper mechanism for engaging the modular head onto the stem. The WMT Modular Ulnar Stem is manufactured from titanium (ASTM F136). The stems will be available in a standard and revision option: the standard stem will be tapered 4.5° to match the anatomical canal geometry while the revision stem will have a 1º taper to match proximal canal geometry. Each stem option will be available in distal diameters ranging from 5.5mm to 8mm and in two lengths: a standard length will have a 1mm platform and 25mm stem, and the extended length will have a 20mm platform and a Image /page/1/Picture/11 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the word "WRIGHT" in a bold, serif typeface. Below "WRIGHT" is the phrase "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The overall design is simple and professional. Image /page/1/Picture/12 description: The image shows a black and white drawing of a globe. The globe is sitting on a stand. The continents of Asia and Australia are visible on the globe. {2}------------------------------------------------ K020a74 Page 3 of 3 50mm stem. The stems will be fluted and will have a heavy grit blast finish over entire part except for the taper. Table 1 is a comparison chart summarizing the above design features for the WMT modular ulnar head implant, the Avanta uHead™ modular ulnar head implant and DCW/WMT Swanson silicone ulnar head implant. | Attribute | WMT modular ulnar<br>head implant | Avanta uHead™<br>modular ulnar head<br>implant | DCW/WMT<br>Swanson silicone<br>ulnar head implant | |-------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------| | Sizes | 8 heads, 6 stems | 3 stems, 3 heads | 7 | | Modularity | Yes | Yes | No | | Locking Mechanism | Taper | Taper | N/A | | Material<br>(head/stem) | Head: CoCr (ASTM<br>F1537 or F799) with<br>plasma spray<br>Stem: titanium alloy<br>(ASTM F136) | Head: CoCr (ASTM<br>F1537, F75 or F799)<br>Stem: CpTi (F67) | Silicone | | Suture Attachments | Yes | Yes | Yes | | Bone Fixation | Cement or Uncemented | Cement or Uncemented | | | Indications | Same | Same | Same | Table 1 - Comparison between WMT modular ulnar head implant, the Avanta uHead™ modular ulnar head implant and DCW/WMT Swanson silicone ulnar head implant ## C. SUBSTANTIAL EQUIVALENCE INFORMATION The intended use, material, type of interface, and design features of the WMT Modular Ulnar Head Implant are substantially equivalent to the Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT - 510(k): K010786). The safety and effectiveness of the WMT Modular Ulnar Head Implant are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification. Image /page/2/Picture/10 description: The image shows a black and white globe. The globe is tilted on a stand. The continents of Asia and Australia are visible on the globe. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the left and its wings outstretched. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 2 2 2002 Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002 Re: K020274 K02027 | Trade Name: WMT Modular Ulnar Head Implant Regulatory Number: 888.3810 Regulatory Number: 888.3610 Regulation Name: Single/multiple component metallic bone fixation fasten Single/multiple component included metallic bone fixation fastener Regulatory Class: II Product Code: KXE Dated: January 25, 2002 Received: January 28, 2002 Dear Mr. Esmail: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Sectori 910(x) premained in substantially equivalent (for the indications referenced above and have determined the device is substantially interstate referenced above and nave determined the devices devices marketed in interstate for use stated in the enclosure) to regally manced provided Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chaomic with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA). and Cosmetic Act (Act) that do not require approval of a provisions of the Act and Cosmetic Act (Act) that do not require as or everal controls provisions of the Act. You may, therefore, market the device, subject to the general registretion, listing You may, therefore, market the device, subject to are stimments for annual registration, listing of The general controls provisions of the Act include requirements for annual The general controls provisions of the Act life. Include required in the branding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (see above) into Existing major regulations affecting your device can may be subject to such additional controls. Existing major and dition EDA may be subject to such additional controller "Extoning thing on to 898. In addition, FDA may be found in the Code of Pouchal Linger in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a succession a such other requirements of the Act that FDA has made a determination that your device complies with other must that FDA has made a determination administered by other Federal agencies. You must or any Federal Statutes and regulations annuding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CFK Part 807), labeling (21 OFR Part 820); and if applicable, the electronic forth in the quanty systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 {4}------------------------------------------------ Page 2 - Mr. Ehab M. Esmail This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icher will anow you to ough maing of substantial equivalence of your device to a legally premarket notication: "The PDF mixing of casification 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 and II you desire specific advice for you invitro diagnostic devices), please contact the Office of additionally 21 CHC Full 007.10 Internally, for questions on the promotion and advertising of Compliance at (301) 274-4657. Tidationally, be questions of (301) 594-4639. Also, please note the your device, prease ochiave and other reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your respeational 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 yours, L. Mula M Mula Celia 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 {5}------------------------------------------------ ## WMT Modular Ulnar Head Implant ### INDICATIONS STATEMENT The WMT Modular Ulnar Head Implant is indicated for the following indications: - Replacement of the distal ulnar head for disorders of the distal radioulnar . joint in rheumatoid, degenerative and post-traumatic arthritis presenting with the following findings: - -pain and weakness of the wrist joint not improved by nonoperative treatment; - -instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint; - -failed ulnar head resection; e.g. Darrach resection - Primary replacement after fracture of the ulnar head or neck. . - Revision following failed ulnar head arthroplasty. ● #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR (Division Sign-Off) Division of General Restorative Devices 510(k) Number > Over-The Counter Use (Optional Format 1-2-96) Prescription Use (Per21 CFR 801.109) Mark N. Millerson (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number. Image /page/5/Picture/20 description: The image shows the Wright Medical Technology logo. The logo consists of a large, stylized letter "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other on the right. Below the logo, there is a line of text that reads "A Wright Medical Group Company". INDICATIONS STATEMENT