SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

{0}------------------------------------------------ KVOZ24 * -My NCV 1 9 2010 # Summary of Safety and Effectiveness Series II X30 Large Diameter Acetabular Inserts Series II X3® Large Diameter Acetabular Inserts uncemented prosthesis, 21 CFR §888.3353 prosthesis, 21 CFR §888.3358 Proprietary Name: Common Name: Classification Name and Reference: Regulatory Class: Product Codes: Class II 888.3350 Hip prosthesis 87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous Hip joint metal/polymer/metal semi-constrained porous coated uncemented Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR 87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented 87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented Predicate Devices: Series II X3 Acetabular Inserts and Trident® X3® Acetabular Insert For Information contact: Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038 estela.celi@stryker.com Date Prepared: October 21st, 2010 {1}------------------------------------------------ Klogl24. *-24 #### Description This Special 510(k) submission is a line extension to address modifications made to the Series II X3ª Acetabular Inserts. The modifications made to the previously cleared Series II X3® Acetabular Inserts (K052748) are as follows: new larger head sizes, an alternate 4mm lateralization (with 0 and 10 degree hood), and additional 0 degree hood design to the existing 6mm lateralization. #### Intended Use The Series II X3® Large Diameter Acetabular Insert is a sterile, single-use device intended for the replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain and the restriction of motion. ## Indications for Use: The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatic 1) arthritis, or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 2) - Clinical management problems where arthrodesis or alternative techniques are less likely to achieve 3) satisfactory results. - Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated of 4) the acetabulum. #### Substantial Equivalence: The Series II X3º Large Diameter Acetabular Inserts are substantially equivalent to the Series II X3º Acetabular Inserts cleared under K052748 and Trident® X3® Large Diameter Acetabular Inserts cleared under K062419 in regards to intended use, design, materials, and operational principles as a hip prosthesis. {2}------------------------------------------------ K108224-#3/4 : # Substantial Equivalence Table with comparison of Technological Characteristics: | Substantial Equivalence Table with Comparison of Technological Characteristics | | | | |--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Series II Comparison of Subject to Predicate | | | | | | Series II X3® Large<br>Diameter Acetabular<br>Inserts | Series II X3®<br>Acetabular Inserts | Trident® X3® Large Diameter<br>Acetabular Insert | | 510(k) | Pending | K052748 | K062419 | | Product Type | Polyethylene Insert<br>Components for Total<br>Hip Arthroplasty | Polyethylene Insert<br>Components for Total<br>Hip Arthroplasty | Polyethylene Insert Components<br>for Total Hip Arthroplasty | | Intended Use | Painful, disabling joint<br>disease of the hip<br>resulting from: non-<br>inflammatory<br>degenerative arthritis,<br>rheumatoid arthritis,<br>post-traumatic arthritis,<br>or late stage avascular<br>necrosis; revision of<br>previous failed femoral<br>head replacement, cup<br>arthroplasty or other<br>procedure; clinical<br>management problems<br>where arthrodesis or<br>alternative<br>reconstructive<br>techniques are less<br>likely to achieve<br>satisfactory results; and<br>where bone stock is of<br>poor quality or<br>inadequate for other<br>reconstructive<br>techniques as indicated<br>by deficiencies of the<br>acetabulum. | Painful, disabling joint<br>disease of the hip<br>resulting from: non-<br>inflammatory<br>degenerative arthritis,<br>rheumatoid arthritis,<br>post-traumatic arthritis,<br>or late stage avascular<br>necrosis; revision of<br>previous failed femoral<br>head replacement, cup<br>arthroplasty or other<br>procedure; clinical<br>management problems<br>where arthrodesis or<br>alternative<br>reconstructive<br>techniques are less<br>likely to achieve<br>satisfactory results; and<br>where bone stock is of<br>poor quality or<br>inadequate for other<br>reconstructive<br>techniques as indicated<br>by deficiencies of the<br>acetabulum. | Painful, disabling joint disease<br>of the hip resulting from: `non-<br>inflammatory degenerative<br>arthritis, rheumatoid arthritis,<br>post-traumatic arthritis, or late<br>stage avascular necrosis;<br>revision of previous failed<br>femoral head replacement, cup<br>arthroplasty or other procedure,<br>clinical management problems<br>where arthrodesis or alternative<br>reconstructive techniques are<br>less likely to achieve<br>satisfactory results, where bone<br>stock is of poor quality or<br>inadequate for other<br>reconstructive techniques as<br>indicated by deficiencies of the<br>acetabulum | | Anatomical Placement | Hip - Acetabular<br>Bearing surface | Hip - Acetabular<br>Bearing surface | Hip - Acetabular Bearing<br>surface | | Sizes Standard | 0°, 10°<br>26mm to 44mm ID | Similar Hood Angle<br>Similar Inner Diameter | Similar Hood Angle<br>Similar Inner Diameter | | Sizes Eccentric | 0°, 10°<br>4 & 6mm lateralization<br>26mm to 44mm ID | Similar Hood Angle<br>Similar Lateralization<br>Similar Inner Diameter | N/A | | Compatible Acetabular<br>Shells | Secur-Fit, Secur-Fit<br>Xtra, Omnifit, PSL,<br>Dual Geometry,<br>Microstructured,<br>Osteonics HA Threaded | Secur-Fit, Secur-Fit<br>Xtra, Omnifit, PSL,<br>Dual Geometry,<br>Microstructured,<br>Osteonics HA Threaded | Trident Hemispherical Solid<br>Back Shells, Trident PSL HA<br>Solid Back Shells, Trident<br>Hemispherical Cluster Shells,<br>Trident PSL HA Cluster Shells,<br>Trident Hemispherical Multi-<br>Hole Shells | | Insert Component Material | UHMWPE | UHMWPE | UHMWPE | | Locking Mechanism | Snap-fit mechanism | Snap-fit mechanism | Press-Fit Mechanism | | Minimum Nominal Dome | 6.43 mm | 5.56 mm | 3.8 mm | | Thickness | | | | | Sterilization Method | Gas Plasma | Gas Plasma | Gas Plasma | {3}------------------------------------------------ K1D312.4 # 4/4 ## Summary of Non-Clinical Testing and Evaluation: The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA).The risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices -Application of risk management to medical devices". Records of the risk analysis process are retained in the design history file. Predicate preclinical testing that was performed: 1) Lever Out Testing (Series II X3® and Trident® X3® Large Diameter) 2) Push Out Testing (Series II X3® and Trident® X3® Large Diameter) 3) Evaluation of Wear Characteristics (Trident® X3® Large Diameter) Based upon the fact that the new Series II X3% Large Diameter Acetabular Inserts represent a line extent Series II X30 Acetabular Inserts the following preclinical testing/evaluation was preformed: Preclinical evaluations performed for the new Series II X3® Large Diameter Acetabular Inserts: 1 ) Poly thickness analysis (Series II X3 and Series II X3 % Large Diameter) 2) Engineering analysis of locking mechanism (Series II X3® and Series II X3® Large Diameter) 3) Engineering analysis of inner diameter, head center, and liner head clearance (Series II X3 ° Large Diameter) The results of the above testing verify that the new device is substantially equivalent to the predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body or wings. The logo is black and white and appears to be a seal or emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Stryker Corporation % Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430 NOV 1 9 2010 Re: K103124 Trade/Device Name: Series II X3® Acetabular Inserts Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO, MEH Dated: October 21, 2010 Received: October 22, 2010 Dear Ms. Celi: 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 application (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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ Page 2 – Ms. Estela Celi 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/CDRH0ffices/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 N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K10324 NOV 1 9 2010 Device Name: Series II X3® Large Diameter Acetabular Inserts Indications for Use: The Series II X30 Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. The indications for use of total hip replacement prostheses include: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, l) post-traumatic arthritis, or late stage avascular necrosis. - 2) Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - 3) Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by 4) deficiencies of the acetabulum. Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Omtu for nxm (Division Sig Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K103124