REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS

{0}------------------------------------------------ OCT 22 1999 K991026 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Reflection® Cross-linked UHMWPE Acetabular Components 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 Reflection® Cross-linked UHMWPE Acetabular Components. | Submitted By: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | March 26, 1999 | | Contact Person: | Ehab M. Esmail<br>Regulatory Affairs Specialist II | | Proprietary Name: | Reflection® Cross-linked UHMWPE Acetabular<br>Components | | Common Name: | Polyethylene Acetabular Components | | Classification Name and Reference: | 21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained,<br>metal/polymer, Cemented – Class II<br>21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained,<br>metal/polymer, Uncemented - Class II | | Device Product Code and Panel Code: | Orthopedics/87/LPH, JDI | #### DEVICE INFORMATION I. ### A. INTENDED USE Total hip components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Image /page/0/Picture/10 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is black and white, with the land masses appearing dark against a light background. The globe is mounted on a stand, and the image is a close-up view of the globe's surface. 1977 1999 1999 1999 1999 1989 1999 1999 1999 1999 1999 1 Refl. Cross-linked UHMWPE Acetabular Comp Leadership in Worldwide Healthcare Smith & Nephew {1}------------------------------------------------ ## B. DEVICE DESCRIPTION The intended use, type of interface, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to the subject identical predicate counterparts fabricated from conventional UHMWPE. ### C. SUBSTANTIAL EQUIVALENCE INFORMATION The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to the subject identical predicate counterpart. The intended use, material, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to predicate competitive devices. While the Reflection® Cross-linked UHMWPE Acetabular Components are not identical to all of the predicates, any differences that may exist do not significantly affect the safety and effectiveness. ## D. WEAR CLAIMS The following marketing claims will be made for the Reflection® Cross-linked UHMWPE Acetabular Components: - 1. Meets all ASTM F648 minimum standards. - 2. No free radicals detectable when analyzed by the ESR technique of the final product. (The detection limit is approximately 1013 spins/gram). - 3. No detectable oxidation as measured by FTIR up to 21 days of accelerated aging at 74℃. - 4. 91.9% reduction in volumetric wear rate versus the identical predicate counterpart fabricated from conventional UHMWPE. Testing was performed in a multiaxial hip joint simulator for min. 3.8 million - max. 5.1 million cycles per individual test using a 32mm wrought CoCr head articulating counterface, a 32mm ID, 56mm OD, minimum thickness 7mm liner with the 20 degree overhang design and Hyclone bovine calf serum as a lubricant. # E. SUMMARY OF TECHNOLOGICAL COMPARISON The intended use, material, type of interface, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are similar to their predicate component counterparts. The raw material used in manufacturing both the subject and predicate devices are UHMWPE per ASTM F-648. The modification to the manufacturing process of this polyethylene resulted in a higher cross-linked polyethylene. The safety and effectiveness of this cross-linked polyethylene in acetabular applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification. Image /page/1/Picture/14 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is depicted in black and white, with the landmasses appearing in solid black against a white background. The curvature of the Earth is visible, and the globe is mounted on a stand, indicated by a curved line above the globe. Leadership in Worldwide Healthcare Smith & Nephew {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three heads. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 22 1999 Mr. Ehab M. Esmail Regulatory Affairs Specialist II Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116 Re : K991026 Trade Name: Reflection Cross-Linked Ultra-High-Molecular-Weight Polyethylene (UHMWPE) Acetabular Components Requlatory Class: II Product Codes: LPH and JDI Dated: July 23, 1999 Received: July 26, 1999 Dear Mr. Esmail: 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. A 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 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 requlatory 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 - Mr. Ehab M. Esmail This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborizon in postantial equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ FDA - ABBREVIATED 510(k) Premarket Notification March 26, 1999 Page 13 of 18 1996 Comments of the United The Property of K991026 # INDICATIONS STATEMENT Reflection® Cross-linked UHMWPE Acetabular Components Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. eneral Restorative Device O(k) Number Prescription Use (Per 21 CFR 801.109) Image /page/4/Picture/8 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is set on a stand, and the continents are clearly visible against the dark background of the oceans. The image is a simple representation of the Earth, highlighting the geographical locations of Asia and Australia. 12 16 2 5 5 3 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 Refl. Cross-linked UHMWPE Acetabular Comp. Leadership in Worldwide Healthcare Smith & Nephew