Klassic Knee System-Sombrero Patella

K150105 · Total Joint Orthopedics, Inc. · JWH · Feb 17, 2015 · Orthopedic

Device Facts

• Record ID: K150105
• Device Name: Klassic Knee System-Sombrero Patella
• Applicant: Total Joint Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - Patients with failed previous surgery where pain, deformity, or dysfunction persists - Correctable varus-valgus deformity and moderate flexion contracture - Revision of a previously failed knee arthroplasty - Patients who require a total knee replacement

Device Story

Klassic Knee System includes Sombrero Patella component for total knee replacement; used with bone cement. Sombrero Patella manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses. Device implanted by orthopedic surgeons in clinical/hospital settings to restore joint function, reduce pain, and correct deformities in patients with degenerative or inflammatory joint disease. Output is physical prosthetic replacement of patella surface. Benefits include improved joint mobility and pain relief.

Clinical Evidence

Bench testing only. Engineering analyses performed to evaluate contact stress and mechanical strength compared to predicate devices.

Technological Characteristics

Ultrahigh molecular weight polyethylene (UHMWPE) patella component; four diameters and two thicknesses; cemented fixation; semi-constrained design.

Indications for Use

Indicated for patients requiring total knee replacement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, correctable varus-valgus deformity, moderate flexion contracture, or revision of failed knee arthroplasty.

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

• Klassic Knee Domed Patella (K112906)
• Zimmer Natural Knee All Polyethylene Patella (K934695)

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

February 17, 2015

Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106

Re: K150105

Trade/Device Name: Klassic 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: January 19, 2015 Received: January 20, 2015

Dear Mr. Weaber:

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. Chris Weaber

(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,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 4. Indications for Use

510(k) Number (if known): K150105

Device Name: Klassic Knee System

The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:

- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### 1. 510(k) Summary

| Device Trade Name: | Klassic™ Knee System |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Total Joint Orthopedics, Inc.<br>1567 E. Stratford Avenue<br>Salt Lake City, UT 84106 |
| Contact: | Mr. Chris Weaber<br>Manufacturing Development Engineer<br>1567 East Stratford Ave.<br>Salt Lake City, Utah 84106<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | January 19, 2015 |
| Classification: | 21 CFR 888.3560, Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis |
| Class: | II |
| Product Code: | IWH |

# Indications for Use:

The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:

- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- Patients with failed previous surgery where pain, deformity, or dysfunction persists •
- Correctable varus-valgus deformity and moderate flexion contracture
- Revision of a previously failed knee arthroplasty •
- . Patients who require a total knee replacement

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# Device Description:

The Sombrero Patella component will be used in conjunction with the Klassic Knee System during total knee replacement. The component is manufactured from ultrahigh molecular weight polyethylene in four diameters and two thicknesses.

# Predicate Devices:

The Sombrero Patella is substantially equivalent to the primary predicate Klassic Knee Domed Patella (K112906) with respect to its intended use, material, geometry, and method of fixation. The Sombrero Patella is also substantially equivalent to the Zimmer Natural Knee All Polyethylene Patella (K934695) with respect to intended use, geometry and method of fixation. The information summarized in the Design Control Activities Summary demonstrates that the Sombrero Patella met the pre-determined acceptance criteria for the verification activities.

## Preclinical Testing:

Engineering analyses were performed on the TIO Sombrero Patella and the previously cleared TJO Domed Patella to evaluate their contact stress and mechanical strength. The results of these analyses indicate that the Sombrero Patella is substantially equivalent to the predicate devices.