TC-PLUS SOLUTION KNEE

K000666 · Plus Orthopedics · JWH · Oct 13, 2000 · Orthopedic

Device Facts

• Record ID: K000666
• Device Name: TC-PLUS SOLUTION KNEE
• Applicant: Plus Orthopedics
• Product Code: JWH · Orthopedic
• Decision Date: Oct 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

TC-PLUS™ Solution Knee is a tri-compartmental total knee prosthesis; includes femoral, patellar, and tibial components. Available in Standard, Posterior Stabilized (PS), and Ultracongruent options to address stability requirements. Designed for cemented surface replacement in primary or revision arthroplasty. Used by orthopedic surgeons in clinical/OR settings. Device restores joint function and stability in patients with degenerative or post-traumatic knee conditions. Biomechanical testing confirms suitability for in vivo loading.

Clinical Evidence

Bench testing only. Biomechanical testing provided to support safety and effectiveness for in vivo loading.

Technological Characteristics

Tri-compartmental total knee prosthesis; components: femoral, patellar, tibial. Materials: Polymer/Metal/Polymer. Configuration: Standard, Posterior Stabilized (PS), and Ultracongruent options. Fixation: Cemented. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to degenerative, post-traumatic, or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic joint configuration loss, patello-femoral erosion, functional disability, prior patellectomy, or moderate varus/valgus/flexure deformity. Contraindications: acute/chronic infection, severe muscular/neurological/vascular deficiency, insufficient bone quality, severe obesity, material allergy, femoral subluxation, ligament instability, severe misalignment, retropatellar degenerative arthritis, or extension contractures >10°.

Regulatory Classification

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

• Encore Foundation Knee System (K923277)

Submission Summary (Full Text)

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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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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 [phone]. 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 [phone], 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)