TC-PLUS SOLUTION KNEE by PLUS ORTHOPEDICS

The TC-PLUS™ Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

Device Description

The TC-PLUS™ Solution is a tri-compartmental total knee prosthesis comprised of femoral, patellar and tibial components with an intrinsic Standard, Posterior Stabilized (PS) and Ultratibial PE-insert. Congruent components are available. The PS is available for indications requiring greater stability and the Ultracongruent option may be used as an alternative for increasing A/P stability.

AI/ML Overview

This document is a 510(k) summary for a knee joint prosthesis, the TC-PLUS™ Solution Knee. It does not describe or include a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, which would be typical for AI/ML-driven devices.

Instead, this submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the Encore Foundation Knee System, K923277) through in vitro biomechanical testing. The acceptance criteria here are implicitly related to industry standards for mechanical strength, wear, and fatigue for knee prostheses, rather than diagnostic or analytical performance.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in the applicable information and explicitly state when a category is not relevant to this type of device submission.

Acceptance Criteria and Device Performance (for a Knee Prosthesis)

Acceptance Criteria Category	Reported Device Performance	Comments
Biomechanical Testing	"All test results are sufficient for in vivo loading."	This is a general statement indicating the device passed relevant biomechanical tests for knee prostheses. Specific numerical thresholds or performance values (e.g., fatigue life, wear rates, load-bearing capacity) are not detailed in this summary document but would have been part of the full submission.
Material Compatibility	Implicitly compatible with human tissue (Polymer/Metal/Polymer components)	The device is made of standard materials used in knee prostheses (polymer, metal) which have established biocompatibility. No specific tests or criteria are mentioned in this summary.
Sterilization Efficacy	Not explicitly stated in this summary.	Sterilization validation would be a standard requirement for such a device, but no performance data is reported here.
Manufacturing Quality	Not explicitly stated in this summary.	Compliance with Quality System Regulation (21 CFR Part 820) is mentioned in the FDA letter, but no specific performance data from quality checks are included in this summary.
Equivalence to Predicate Device	Substantially equivalent to the Encore Foundation Knee System (K923277, SE date 02/09/93).	This is the primary "acceptance criterion" for a 510(k) pathway – demonstrating the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparison of indications, technological characteristics, and performance data (like biomechanical testing).

Study Details (as inferrable for a traditional medical device like a knee prosthesis)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of device performance in a diagnostic or analytical sense. For biomechanical testing, the "sample size" would refer to the number of prosthetic components tested for each specific mechanical property (e.g., fatigue, wear). This information is not provided in the 510(k) summary but would be detailed in the full biomechanical test reports submitted to the FDA. Data provenance would be from laboratory testing.
- Data Provenance: Laboratory testing of manufactured components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context typically refers to objective measurements or engineering standards established by qualified engineers and scientists in biomechanics, materials science, etc., rather than expert clinical consensus as defined for AI/ML models.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a concept used in expert consensus for diagnostic interpretation. Biomechanical testing relies on objective measurements against engineering specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical prosthetic device, not a diagnostic imaging AI algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical prosthetic device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biomechanical testing, the "ground truth" is defined by established engineering principles, material science properties, regulatory standards (e.g., ISO, ASTM for orthopedics), and comparative performance against the predicate device. It's objective, quantitative data from physical tests.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a "training set." Device design and materials development are based on extensive prior knowledge and engineering principles, not machine learning model training.
How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.

Summary

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510(k) Summary of Safety and Effectiveness

August 24, 2000

Contact: Hartmut Loch, C.E.O. PLUS ORTHOPEDICS 3550 General Atomics Court, Bldg. 15-100 San Diego, CA 92121
TC-PLUS™ Solution Knee Trade name:
Knee Joint Prosthesis Common name:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Classification name: Polymer/Metal/Polymer
Encore Foundation Knee System (K923277, SE date 02/09/93) Equivalence:
The TC-PLUS™ Solution is a tri-compartmental total knee prosthesis Characteristics: comprised of femoral, patellar and tibial components with an intrinsic Standard, Posterior Stabilized (PS) and Ultratibial PE-insert. Congruent components are available. The PS is available for indications requiring greater stability and the Ultracongruent option may be used as an alternative for increasing A/P stability.
The TC-PLUS™ Solution Knee is intended as a cemented surface Indications: replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for post-traumatic or rheumatoid arthritis, avascular degenerative, necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
Contraindications include acute or chronic infections (local or Contraindications: systemic) or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity; bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment; retropatellar degenerative arthritis; extension contractures over 10°.
Biomechanical Testing has been provided. Performance data: All test results are sufficient for in vivo loading.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2000

Mr. Hartmut Loch Chief Executive Officer PLUS Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122

Re: K000666

Trade Name: TC-PLUS Solution Knee Regulatory Class: II Product Code: JWH Dated: August 24, 2000 Received: August 25, 2000

Dear Mr. Loch:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notification of the indications for use indications for use above and we nave determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the enclosure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Device Frinencine, or we and Cosmetic Act.(Act). You may, a therefore, market the device, subject to the general control provisions of the Act. The general therefore, market the device, subject to the generatis for annual registration, listing of devices to control provisions of the Ace merade requirements instranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see above) anto such additional controls. Existing major.regulations (Premarket Approval), it may of subject to ace of Federal Regulations, Title 21, Parts 800 to 895. arrecting your de rive eant determination assumes compliance with the current Good A substantiany equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the rood and Drug Nammedia in to allatory action. In addition, FDA may publish Continy with the GMI Togatazen in the Federal Register. Please note: this response to your premarks contring your submission does not affect any obligation you might Its pour premainter as and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Hartmut Loch

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific davice for your actic devices), please contact the Office of Compliance at additionally 807.10 for in Vitto diagnostions on the promotion and advertising of your device, (2017) 594-4037. Additionally, for quose at (301) 594-4639. Also, please note the regulation prease connect the Orneo or Somphares et premarket notification" (21 CFR 807.97). Other general entitled, "Misoranding by relection to premation to may be obtained from the Division of Small information on your responsionneer and its tollows 38-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark n Mellausen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k) TC-PLUS™ Solution Knee August 24, 2000

Page 1 of 1

510(k) Number (if known): _KOOO 666

Device Name: TC-PLUS™ Solution Knee

Indications for Use:

The TC-PLUS™M Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milliman

Division Sign-C (Division of General Restorative 510(k) Number

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(Optional Format 1-2-96)

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.