Progressive Orthopedic Total Knee System

K142649 · The Progressive Orthopaedic Company, LLC · JWH · Mar 24, 2015 · Orthopedic

Device Facts

• Record ID: K142649
• Device Name: Progressive Orthopedic Total Knee System
• Applicant: The Progressive Orthopaedic Company, LLC
• Product Code: JWH · Orthopedic
• Decision Date: Mar 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.

Device Story

Fixed-bearing, posterior-stabilized total knee prosthesis; consists of femoral component, tibial tray, tibial insert, and patellar component. Designed for cemented implantation in knee arthroplasty. Femoral component articulates with tibial insert; tibial insert snaps into tibial baseplate. Dome-shaped UHMWPE patellar component distributes stress and simplifies implantation. Device restores natural femoral anatomy, rotation, extension, and flexion. Used by orthopedic surgeons in clinical settings to treat severe knee pain and disability. Benefits include pain reduction, improved joint function, and stabilization of failed prior surgical attempts.

Clinical Evidence

Bench testing only. Evaluated fatigue performance of tibial tray, interlock mechanism strength, shear fatigue strength of tibial insert post, contact pressures/areas, lateral subluxation of patellar component, and range of motion. Results demonstrate performance equivalent to the predicate device.

Technological Characteristics

Fixed-bearing, posterior-stabilized, semi-constrained cemented prosthesis. Materials: metal and UHMWPE (Ultra-High Molecular Weight Polyethylene). Components: femoral, tibial tray, tibial insert, patellar. Design features modular sizing allowing cross-matching of femoral and tibial components.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for pain relief or improved function due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, avascular necrosis, pseudogout, or posttraumatic joint loss; includes salvage of failed surgical attempts. Contraindicated for patients without skeletal maturity.

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

• United Orthopedic U2 Total Knee (K051640)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2015

The Progressive Orthopaedic Company, LLC Mr. Thomas Smith Quality/Regulatory Consultant 801 US Highway 1, Suite B North Palm Beach, Florida 33408

Re: K142649

Trade/Device Name: Progressive Orthopaedic Total Knee 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: December 19, 2014 Received: December 24, 2014

Dear Mr. Smith:

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

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Page 2 - Mr. Thomas Smith

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for 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) K142649

Device Name

Progressive Orthopaedic Total Knee System

#### Indications for Use (Describe)

The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif"> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(k) Summary

| Applicant/Sponsor: | The Progressive Orthopaedic Company, LLC.<br>801 US Highway 1, Suite B<br>North Palm Beach, FL, 33408<br>[phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Smith<br>Quality and Regulatory Consultant<br>801 US Highway 1, Suite B<br>North Palm Beach, FL, 33408<br>[phone] |
| Date Prepared: | September 15, 2014 |
| DEVICE INFORMATION | |
| Proposed Trade Name: | Progressive Orthopaedic Total Knee System |
| Common Name: | Semi-constrained total knee prosthesis |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis per 21CFR 888.3560. This<br>falls under the Orthopedics panel/87 as a Class II device. |
| Device Product Code: | JWH |
| Predicate Device: | United Orthopedic U2 Total Knee (K051640) |

#### Device Description:

The Progressive Orthopaedic Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.

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### Intended Use:

#### Total knee arthroplasty

### Indications for Use:

The Progressive Orthopaedic Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The Progressive Orthopaedic Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.

### Summary of Technological Characteristics

The Progressive Orthopaedic Total Knee System has the same intended use and indications as the U2 Total Knee system. The Progressive Orthopaedic Total Knee System is manufactured from the same materials as the U2 Total Knee system. The range of sizes available for the Progressive Orthopaedic Total Knee System is the same as the range of sizes cleared for the U2 Total Knee system. The Progressive Orthopaedic Total Knee System design is substantially similar to the U2 Total Knee system design. Based on these similarities, The Progressive Orthopaedic Company believes that the Progressive Orthopaedic Total Knee System is substantially equivalent to the U2 Total Knee system.

#### Performance Testing

The Progressive Orthopaedic Total Knee System was tested for fatigue performance of the tibial tray, interlock mechanism strength (between the tibial insert), shear fatigue strength of the tibial insert post, contact pressures and areas, lateral subluxation of patellar component, and range of motion performance. Test results indicate that the Progressive Orthopaedic Total Knee System performs as well as the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure.