QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT

{0} K964616 # 510(k) SUMMARY AUG - 7 1997 ## Device: Classification Name: Prosthesis Hip, Semi-constrained, Metal / Polymer, Porous Uncemented Classification No.: 87LPH Common / Usual Name: Modular femoral component Proprietary Name: Quatroloc Plasma Sprayed Femoral Component ## Manufacturer Identification: Whiteside Biomechanics, Inc. 12634 Olive Blvd. St. Louis, MO 63141 Establishment Registration Number: 1932213 ## Device Description: The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4V (ASTM 1472) stem with a tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior—posteriorly and will have step-cut sides medial—laterally. The proximal stem will be porous coated with commercially pure titanium plasma spray on all surfaces excluding the articular interface trunnion. ## Intended Use: This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, and 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. ## Additional Information: This femoral component is made of wrought titanium 6Al-4V(ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunnion. The device is provided sterilized and packaged. Sterilization will be provided by 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Michael C. Wall, R.N. Official Correspondent Whiteside Biomechanics 12634 Olive Boulevard St. Louis, Missouri 63141 AUG - 7 1997 Re: K964616 Trade Name: Quatroloc Plasma Sprayed Femoral Components Regulatory Class: II Product Code: LPH Dated: May 14, 1997 Received: May 19, 1997 Dear Mr. Wall: 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 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 (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. A substantially equivalent determination assumes compliance with {2} Page 2 - Michael C. Wall, R.N. the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(C) the device cleared for marketing by this letter as requiring postmarket surveillance. The rationale for this decision is contained in the enclosed attachment. Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached. Submit five (5) copies to: Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850 {3} Page 3 - Michael C. Wall, R.N. Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803). Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(1)(C) of the Act (21 U.S.C. 331 (q)(1)(C). Further, under section 502(t)(3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties. If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 {4} Page 4 - Michael C. Wall, R.N. 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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} 04/22/96 12:52 301 480 3002 FDA CDRH ODE 002 Answer #3 Page 1 of 1 510(k) Number (if known): k964616 Device Name: Whiteside Biomechanics Inc. Quatroloc Plasma Sprayed Femoral Component ## Indications For Use: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis, 3. correction of functional deformity, 4. revision procedures where other treatments or devices have failed, 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. (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 ☐ (Optional Format 1-2-96)