CORIN METAFIX HIP STEM

{0}------------------------------------------------ DEC 16 2013 #### K131952 ## 3. 510(K) SUMMARY 1. Applicant/Sponsor: Corin USA 5670 W. Cypress Street Suite C Tampa, Florida 33607 Establishment Registration No.:1056629 Contact Person: Lucinda Gerber 2. Regulatory Affairs Associate Corin USA 813-977-4469 lucinda.gerber@coringroup.com Kathy Trier VP US Regulatory and Global Clinical Affairs Corin USA 813-977-4469 kathy.trier@coringroup.com 3. Date: June 26, 2013 Corin MetaFix I-Iip Stem 4. Proprietary Name: Common Name: Hip Prosthesis 5. 6. Product Codes: LZO, KWL, KWY, MEH, OQI, 7. Classification Name: . Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21CFR 888.3390) . Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360) Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented . prosthesis (21CFR 888.3353) {1}------------------------------------------------ #### K131952 #### 8. Legally Matketed Devices to which Substantial Equivalence is claimed: - Corin MetaFix Hip Stem (K082525) . - Corin MetaFix size 1 (K121439) . - Corin MetaFix Hip Stem with Hemi-Arthroplasty (K120362) ● - Corin MetaFix Hip Stem (K130634) ● - . Corin Trinity Acetabular System with XL Heads (K130343) #### 9. Device Description: The Corin MetaFix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAl, V.) alloy for surgical implant applications, conforming to ASTM F136-12a and is coated with plasma sprayed hydroxyapatite conforming to ASTM F1185-03(2009). The Corin MetaFix Hip Stem is available in 10 sizes marked 1 through 10. With size 2 to 10 available in three offsets, including Standard (1359), Lateralized, (1359), and Standard (125°) and size 1 available in two offsets Standard (135°), Lateralized (135°). The Corin MetaFix Hip Stems were originally cleared in K082525 & K121439 and indications and contraindications of hemi arthroplasty and compatible components were added in K120362 & K130634. Modular CoCrMo Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0.0mm (standard) and, +3.5mm (long) offsets and diameter of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) and +4mm (long) as previously cleared in K093472 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343. Modular BIOLOX delta™ Ceramic Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0mm (standard) and, +3.5mm (long) offsets and diameters of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) +4mm (long) as previously cleared in K103120 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343. The Corin MetaFix Hip Stern was originally cleared in K082525, K121439, K120362 and K130634 and as cleared, compauble with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MeraFix Hip Stem to include an additional size of the compatible femoral heads. The addition is for three offsets in the CoCrMo and Ceramic extra-long heads, 32mm (+7mm), 36mm (+8mm) and 40mm (+8mm). {2}------------------------------------------------ #### 10. Intended Use / Indications: The indications for the Corin MetaFix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis . - . Rheumatoid arthritis - Correction of functional deformity � - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur . - Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDI-I) . The Corin MetaFix Hip Stem is intended for cementless use only. #### 11. Summary of Technologies/Substantial Equivalence: MetaFix Stems, subject of this submission, are identical to the predicate devices. This submission adds compatible modular femoral heads in an extra-long offset and is submitted for a modification of labeling. The additional compatible components of the Corin Metalix. Hip Sten, subject device, are identical to predicate Trinity Acetabular System with XL Heads (K1303-13). compatible components, in terms of materials, intended use and indications and similar in design. Based on these similarities, Corin believes the MetaFix Hip Stems, subject of this submission that they are substantially equivalent to the predicate devices. #### 12. Non-Clinical Testing: Non-clinical testing conducted to demonstrate substantial equivalence includes a comparison of compatible components with the predicate devices. #### 13. Clinical Testing: Clinical testing was not necessary to determine substantial equivalence between the additional compatible components of the Corin MetaFix Hip Stem and the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of curved lines. The overall design is simple and monochromatic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 16, 2013 Corin USA Lucinda Gerber, BA (Hons) Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607 Re: K131952 Trade/Device Name: Corin MetaFix Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWL, KWY, MEH, OQI Dated: November 7, 2013 Received: November 8, 2013 Dear Ms. Gerber: 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 {4}------------------------------------------------ ### ······· Page 2-Lucinda Gerber, BA (Hons) forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53.1-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note, the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industrv/default.htm. Sincerely yours, # Ronald BAJean -S for - · Mark N. Melkerson Director Division of Orthopedic Devices - Office of Device Evaluation Center for Devices and - Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE 2. 510(k) Number (if known): K131952 Device Name: Corin Metafix Hip Stem Indications for Use: " ﻧﺴﺒﺔ ﺍﻟﺘﻬﺪﻳﺔ ﺍﻟﻤﻠﻜﺔ The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-atthroplasty femoral heads, as a hemi-arthroplasty, include: - . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis . - . Correction of functional deformity - . Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip � (CDH) The Corin Metafix Hip Stem is indicated for cementless use only. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Elizabeth L. Frank -S Page 1 of 1 Division of Orthopedic Devices Page 6 of 210