TC-PLUS POROUS FEMORAL COMPONENTS

K011258 · Plus Orthopedics · JWH · May 24, 2001 · Orthopedic

Device Facts

• Record ID: K011258
• Device Name: TC-PLUS POROUS FEMORAL COMPONENTS
• Applicant: Plus Orthopedics
• Product Code: JWH · Orthopedic
• Decision Date: May 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TC-PLUS™ Porous Femoral Component 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 surgerv.

Device Story

TC-PLUS™ Porous Femoral Components are orthopedic implants for total knee arthroplasty; designed as cemented surface replacements. Device modification involves addition of Ti-Plasma coating to underside of femoral components; geometry, material, and indications remain identical to predicate. Used by orthopedic surgeons in clinical settings for patients with degenerative, post-traumatic, or rheumatoid arthritis and related joint deformities. Implants provide structural replacement for femoral condyles; intended to restore joint function and alleviate disability. Biomechanical testing confirms equivalence to predicate for in vivo loading.

Clinical Evidence

Bench testing only. Biomechanical tests performed to compare modified components to the predicate device; results confirmed equivalence and sufficiency for in vivo loading.

Technological Characteristics

Femoral knee prosthesis component; Ti-Plasma coated metal; intended for cemented use only. Available in sizes 2, 4, 6, 8, 10, and 12. No software or electronic components.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to degenerative, post-traumatic, or rheumatoid arthritis, avascular necrosis, joint configuration loss, patello-femoral erosion, functional disability, prior patellectomy, or moderate varus/valgus/flexure deformity. Contraindicated in patients with acute/chronic local or systemic infections, serious muscle/nerve/blood vessel lesions, poor bone quality/defects, or concurrent diseases interfering with implant function.

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

• TC-PLUS® Solution Knee System (K000666)

Submission Summary (Full Text)

{0}------------------------------------------------

K01/1258

# MAY 2 4 2001

### Appendix V

SUMMARY

OF

## SAFETY AND EFFECTIVENESS INFORMATION

{1}------------------------------------------------

K011 258

PAGE 1 OF 2

### 510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

Contact:

Mr. Hartmut Loch, RAC Director, Regulatory Affairs Plus ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121-2700 Tel: [phone]

TC-PLUS™ Porous Femoral Components Trade Name:

Cemented Knee Prosthesis Common Name:

Prosthesis Knee, Patelllofemorotibial, Semi-Constrained, Cemented, Classification Polymer/Metal/Polymer Name:

21 CFR 888.3560 Classification

Number:

Class II Device Class:

87 Orthopedic Devices Panel Classification

Panel:

Product Code: JWH

TC-PLUS® Solution Knee System, which was cleared for marketing in Predicate Device: the U.S.A. by FDA (K000666 S/E 10/13/2000) and is also manufactured by PLUS Endoprothetik AG, Switzerland

Device Modification Description:

The TC-PLUS™ Porous Femoral Components are identical to the predicate device, except that they are Ti-Plasma coated on the underside. They are identical in indications for use, geometry, material, and surface characteristics to the predicate device, and they are intended for use only with bone cement. These additional porous coated femoral components are available in right and left, sizes 2, 4, 6, 8, 10, and 12.

The tibial components as well as the tibial PE inserts have not been changed and are identical to the predicate device.

{2}------------------------------------------------

PAGE 2 OF 2

#### Indications:

The TC-PLUS™ Porous Femoral Component 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 surgerv.

## Contraindications:

Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.

### Performance data:

Biomechanical tests have been performed. The test results are included in this submission and show that the additional components were equivalent to the predicate device and are sufficient for in vivo loading.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2001

Mr. Hartmut Loch Director, Regulatory Affairs Plus Orthopedics 6055 Lusk Boulevard San Diego, California 92121

Re: K011258

Trade Name: TC-PLUS™ Porous Femoral Component Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: April 23, 2001 Received: April 24, 2001

Dear Mr. Loch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{4}------------------------------------------------

#### Page 2 - Mr. Hartmut Loch

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Traditional [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

втирвееттот

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

{5}------------------------------------------------

Page 1

510(k) Number: k0 11258

Device Name(s):

TC-PLUS™ Porous Femoral Components

Indications for Use:

The TC-PLUS™ Porous Femoral Component 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, posttraumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patellofemoral 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 NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mihailescu for emu

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number: 011258

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional format 1-2-96)

6