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.

AI/ML Overview

The acceptance criteria and study proving they are met are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "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." This implies that the acceptance criteria for the new specifications (additional sizes of femoral components, tibial base plates, and patellar components) were met by demonstrating that they do not worsen the performance of the previously cleared predicate devices. The "reported device performance" is essentially that the new components maintain the same safety and effectiveness as the predicate devices, as determined by engineering analysis rather than new physical performance testing.

Acceptance Criterion	Reported Device Performance
The inclusion of additional specifications (new sizes of femoral components, tibial base plates, and patellar components) does not change the worst-case configuration performance for the LOSPA TKR System compared to previously cleared predicate devices (K110404 & K121037).	Engineering analysis demonstrated that the inclusion of additional specifications did not change the worst-case configuration tested in K110404 & K121047. The technological characteristics are similar to predicate devices, and no new issues of safety or efficacy are raised.

2. Sample Size Used for the Test Set and Data Provenance:

No explicit "test set" in the traditional sense of a clinical or bench performance test with a specific sample size is mentioned for this 510(k) submission. The decision was based on engineering analysis and comparison to predicate devices. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to a test set is not applicable here as no new performance data was generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. As described, no new performance testing with a "test set" requiring ground truth establishment by experts was conducted for this specific submission. The assessment was based on engineering analysis and leveraging existing performance data from predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the traditional sense that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states that "Performance testing - Bench, was not required." Therefore, no MRMC study, or any clinical study, was conducted to compare human reader performance with or without AI assistance, as AI is not mentioned as a component of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. The device is a total knee replacement system, which is a physical implant, not a software algorithm. Therefore, "standalone algorithm-only performance" is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for proving the acceptance criteria was established through engineering analysis, essentially demonstrating that the design principles and materials of the new component sizes are consistent with and do not negatively impact the established safety and efficacy of the predicate devices. This relies on the established performance and safety profiles of the predicate devices and the understanding of material properties (ASTM standards) and manufacturing processes.

8. Sample Size for the Training Set:

Not applicable. The device is a physical knee replacement system, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for this device, the establishment of ground truth for such a set is not relevant.

Summary

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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.

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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

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

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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.

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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

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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

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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

Regulation Number and Section

§ 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.