DUAL LOCK HIP STEM

{0}------------------------------------------------ MAY 20 1998 1 136 K980794 DePuy. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NAME OF FIRM: 510(K) CONTACT: DePuy, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Arlene C. Saull, RAC Sr. Submissions Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. IN 46581-0988 Phone: 219-372-7176 Dual Lock® Hip Stem Cemented hip prosthesis TRADE NAME: COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE: 87 JDI: Prosthesis, Hip, Semi-Constrained Metal/Polymer, Cemented constrained cemented prosthesis Class II per 888.3350: Hip joint, metal/polymer semi- DePuy Prodigv Hip SUBSTANTIALLY DePuy Cemented Hip Prosthesis EQUIVALENT DEVICES: DePuy Porocoat Dual Lock Total Hip System ## DEVICE DESCRIPTION AND INTENDED USE: The Dual Lock Hip Stem system consists of variously sized femoral hip stems made from Cobalt Chrome which will be available with standard and lateral offsets. The Dual Lock Hip Stems are designed with neck tapers intended to be used with DePuy femoral ball heads made from Cobalt Chrome or Zirconia Ceramic, and DePuy acetabular components with ultra high molecular weight polyethylene articulating surfaces. The Dual Lock Hip Stem is intended for use as the cemented femoral component in total hip arthroplasty for the treatment of: - 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; - 2. Avascular necrosis of the femoral head; - 3. Acute traumatic fracture of the femoral head or neck; - 4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; - 5. Certain cases of ankylosis. Page 1 of 2 #### DePuv Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Telephone: + 1 (219) 267 8143 Fax: + 1 (219) 267 7196 ## 000005 {1}------------------------------------------------ #### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### BASIS OF SUBSTANTIAL EQUIVALENCE: The subject Dual Lock Hip Stem is similar in material (Cobalt Chrome), design, sizing, and intended use (with cement) to the DePuy Porocoat Dual Lock Total Hip System previously cleared by FDA for cemented use, except the subject device does not employ porous coating on the stem. The modular neck taper of the subject Dual Lock Hip Stem is identical to the DePuy Prodigy Hip, also previously cleared via 510(k). They are both intended for use with the same DePuy femoral hip balls which are legally marketed devices. The offsets available with the subject device are similar to those of the DePuy Cemented Hip Prosthesis which was previously cleared via 510(k). Based on the information supplied in this premarket notification submission, DePuy believes that the subject Dual Lock Hip Stem is substantially equivalent in terms of materials, design, sizing and intended use to the predicate DePuy Porocoat Dual Lock Total Hip System, the DePuy Prodigy Hip, and the DePuy Cemented Hip Prosthesis (all cleared via 510(k)). It is expected that the performance of the subject DePuy Dual Lock Hip Stem will be similar to these predicate devices. Signature: Darlene C. Saull Date: February 26, 1998 END OF 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FORM Page 2 of 2 # 000007 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with outstretched arms, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 20 1998 Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K980794 Dual Lock® Hip Stem Trade Name: Requlatory Class: II Product Code: JDI February 27, 1998 Dated: March 2, 1998 Received: Dear Ms. Saull: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Fred and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatery In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ### Page 2 - Arlene C. Saull, RAC This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation · Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### INDICATIONS | 510(k) Number (if known) | 980794 | |--------------------------|--------| |--------------------------|--------| Dual Lock® Hip Stem Device Name Indications for Use: The Dual Lock Hip Stem is indicated for use as the cemented femoral component in total hip arthroplasty for the treatment of: - 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; - 2. Avascular necrosis of the femoral head; - 3. Acute traumatic fracture of the femoral head or neck; - Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; - Certain cases of ankylosis. ર. Concurrence of CDRH, Office of Device Evaluation: bocce sion of General Restorative Devices 510(k) Number . | Prescription Use | X | OR | |------------------|---|----| |------------------|---|----| Over-The Counter Use ____(Per 21 CFR 801.109) # 000003