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LOSPA TKR 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.
LOSPA TKR System is intended for cemented application only.

EXULT Knee System is intended for the treatment of diseases as follows:
· 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.
EXULT Knee System is intended for cemented application only.

The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures.

LOSPA Modular Knee System Instruments: Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs. Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs.

EXULT Knee System Instruments: AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for Corentec Co., Ltd.'s LOSPA TKR System Instrumentation and EXULT TKR System Instrumentation. It primarily discusses the administrative details of the clearance, the indications for use of the devices, and a comparison to legally marketed predicate devices to establish substantial equivalence.

Specifically, the document states:

• No Clinical or Animal Testing: "No clinical or animal testing were required." (Page 6)
• Non-Clinical Testing: "The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence: ・ Dimensions measurement testing ・ Assembly testing" (Page 6)

Therefore, I cannot provide the requested information, which requires details about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The clearance was based on dimensional measurements and assembly testing, not on clinical performance metrics typically associated with acceptance criteria for device efficacy or diagnostic accuracy.

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