← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K130673 # LOSPA TOTAL KNEE REPLACEMENT SYSTEM (K130673) _Corentec Co., Ltd. · JWH · Apr 15, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K130673 ## Device Facts - **Applicant:** Corentec Co., Ltd. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Apr 15, 2013 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications: - Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; - Post-traumatic loss of knee joint configuration and function; - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The LOSPA Total Knee Replacement System is intended for cemented use only. ## Device Story LOSPA TKR System is a semi-constrained, cemented total knee replacement prosthesis. Components include femoral components (CR/PS designs), tibial base plates, tibial inserts, and patellar components. System replaces damaged knee joint surfaces to restore function and alleviate pain. Used by orthopedic surgeons in hospital settings during total knee arthroplasty. Device provides mechanical structural support and articulation for the knee joint. Benefits include correction of deformities and improved joint mobility. This submission adds new component sizes to existing cleared system. ## Clinical Evidence No clinical data. Bench testing not required as engineering analysis demonstrated that additional sizes do not change the worst-case configuration previously validated in K110404 and K121037. ## Technological Characteristics Semi-constrained, cemented knee prosthesis. Femoral and tibial components: Cobalt-chromium-molybdenum alloy (ASTM F75). Tibial inserts and patellar components: UHMWPE (ASTM F648, Type 1, GUR 1020). Available in CR and PS designs. Sterile supply. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Corentec Co., Ltd., Eaum Total Knee System ([K110404](/device/K110404.md)) - Corentec Co., Ltd., LOSPA Tibial Base Plate ([K121037](/device/K121037.md)) - Howmedica Osteonics Corp. (Stryker) Scorpio 'NRG' Knee ([K030978](/device/K030978.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K130673 (1/3) Special 510(k): Specification Inclusion LOSPA TKR System # 510(K) SUMMARY APR 1 5 2013 ## Corentec Co., Ltd. # LOSPA TKR System - Spec Inclusion 5nd March, 2013 #### ADMINISTRATIVE INFORMATION Corentec Co., Ltd. Manufacturer > 247 Giro-ri, Ipjang-myeon, Seobuk-Gu Cheonan-si. Chungchongnam-do. 331-822 South Korea Telephone: +82-41-585-7114 Fax: +82-41-585-7113 Official Contact J.S. Daniel Project Manager - RA/QA Corentec Co.. Ltd 8th Chungho Tower. 748-1 Banpo 1 Dong Seocho Gu, Seoul, Korea 137-040 Ph: +82 70 4393 3819 Fax: +82 2 3445 5467 Email: jsdaniel@corentec.com ### DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name: LOSPA TKR System Total Knee Joint Replacement Prosthesis Common Name: Classification Regulations: 21 CFR 888.3560 Class: I I Product Codes: JWH Classification Panel: Orthopedic Products Panel Reviewing Branch: Orthopedic Devices Branch #### INTENDED USE The intended use of the added specification has not changed us a result of the modification of the predicate device cleared under Lospa Total Knee System, K110404 & K121037. {1}------------------------------------------------ The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications: - Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; - Post-traumatic loss of knee joint configuration and function; � - Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability; - Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of . previous arthroplasty procedure. The LOSPA Total Knee Replacement System is intended for cemented use only. #### DEVICE DESCRIPTION The LOSPA TKR System specification inclusions are components of "LOSPA Total Knee System" cleared under K110404 & K121037 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation -LOSPA Total Knee Instrumentation for use with the system implant components. #### Femoral Components Femoral components are available in CR and PS designs. There are five additional sizes, #6. 8#. #12, #14 & #16 of each design (CR and PS), each for left and right sides. For both the CR and PS designs, the ranges of dimensions are the same. All femoral components are manufactured from cobalt-chromium-molybdenum alloy conforming to ASTM F75, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075). #### Tibial Base plate The tibial base plate, are made available in additional sizes, #6, 8#, #14 & #16, to provide optimal tibial coverage. The tibial base plates are designed for use in either the left or right side, and with either CR or PS femoral components and corresponding tibial inserts. All tibial base plate components are manufactured from cobalt-chromiummolybdenum alloy conforming to ASTM F75, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075). #### Tibial Inserts Additional size tibial inserts corresponding to tibial base plate, are made available in sizes, #6, #13, #14 & #16, to provide optimal tibial coverage. Tibial inserts are available for both the CR and PS designs. The ultra-high molecular weight polyethylene (UHMWPE) tibial inserts is provided with bearing surfaces in various thicknesses. The polyethylene used for all tibial inserts is {2}------------------------------------------------ manufactured from UHMWPE conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 1 (GUR 1020). ### Patellar Components Patellar components cleared in K110404 are provided in two types, dome and sombrero. This submission includes only dome type. Additional sizes are included to offer a wide choice in the term of 'thickness' & 'peg distance' than existing approved specifications. The polyethylene used for all patellar components is manufactured from UHMWPE conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 1 (GUR 1020). All sizes of the patellar components are compatible with all sizes of the femoral components. The design of the patella component is exactly same as the device cleared in K110404. ### SUBSTANTIAL EQUIVALENCE LOSPA TKR System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below, - · Corentec Co., Ltd., Eaum Total Knee System (now renamed as LOSPA Total Knee System) cleared under K110404 - Corentee Co., Ltd., LOSPA Tibial Base Plate, cleared under K121037 . - Howmedica Osteonics Corp. (Stryker) Scorpio 'NRG' Knee cleared under . K030978 ## PERFORMANCE TESTING Performance testing - Bench, was not required since engineering analysis showed that the inclusion of additional specification did not change the worst case configuration tested in both K110404 & K121037. Also the predicate device Scorpio 'NRG' Knee cleared under K030978 has similar specification as the additional specification included in this submission. Also the Scorpio 'NRG' Knee cleared under K030978 was used as a predicate device in LOSPA TKR System approval in both K110404 & K121037. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. Overall, the LOSPA TKR System components has similarities to the predicate device/s with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 15, 2013 Corentec Co., Ltd % J.S. Daniel Project Manager - RA/QA 8" Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu. Seoul 137-040 South Korea Re: K130673 Trade/Device Name: LOSPA Total Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 28, 2013 Received: April 2, 2013 Dear J.S. Daniel: 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 {4}------------------------------------------------ #### Page 2 - J.S. Daniel device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely vours. Image /page/4/Picture/7 description: The image shows the name "Erin I.D. Keith" in a stylized font. The name is written in black ink and is centered in the image. The letters "I.D.K" are stylized with multiple lines and shapes, making them stand out from the rest of the name. The overall design is simple but eye-catching. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K130673 Device Name: LOSPA Total Knee Replacement System The Lospa Total Knee Replacement System is intended for use in total knee arthroplasty surgery for the following indications: - Painful, disabling joint disease of the knee resulting from non-inflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; - Post-traumatic loss of knee joint configuration and function; . - Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability; - Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of . previous arthroplasty procedure. The LOSPA Total Knee Replacement System is intended for cemented use only. Prescription Use: X (Per 21 CFR 801 Subpart D) AND / OR · . Over-The Counter Use :-(Per 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) | Casey L. Hanley, Ph.D. | |--------------------------------| | Division of Orthopedic Devices | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K130673](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K130673) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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