(34 days)
No
The document describes a standard knee replacement system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a knee replacement system intended for total knee arthroplasty surgery to treat painful, disabling joint disease and restore joint configuration and function, which constitutes a therapeutic purpose.
No
This device is a total knee replacement system, which is a prosthetic implant used in surgical procedures to replace damaged knee joints. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists hardware components (Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components, and Instrumentation) and refers to previous clearances for these physical implants and tools.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the Lospa Total Knee Replacement System consists of components like Femoral Components, Tibial Base plate, Tibial Insert, and Patellar Components. These are implants designed to be surgically placed inside the body to replace a damaged knee joint.
- Intended Use: The intended use is for "total knee arthroplasty surgery," which is a surgical procedure to replace the knee joint. This is an in vivo (within the living body) procedure, not an in vitro (in glass, or outside the body) diagnostic test.
The information provided describes a surgical implant system, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for 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.
Product codes
JWH
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 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).
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).
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
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 |