Klassic HD® Hip System

K171962 · Total Joint Othopedics, Inc. · LPH · Jul 24, 2017 · Orthopedic

Device Facts

• Record ID: K171962
• Device Name: Klassic HD® Hip System
• Applicant: Total Joint Othopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 24, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of a previously failed hip arthroplasty. - Patients who require a total hip replacement.

Device Story

Klassic HD® Hip System consists of femoral hip stems designed to restore hip joint biomechanics. Device used by surgeons in clinical settings for total hip replacement or revision arthroplasty. System functions as prosthetic replacement for diseased or damaged hip joints. This specific submission introduces larger sizes of Klassic® Blade Femoral Stems and a new material for previously cleared Klassic® Blade Femoral and Offset Femoral Stems. Surgeons utilize these implants to replace femoral components, aiming to alleviate pain and restore function. Benefits include improved joint mobility and stability for patients with degenerative or inflammatory joint conditions.

Clinical Evidence

No clinical data. Evidence consists of bench testing, specifically worst-case fatigue testing and porous coating characterization, demonstrating performance equivalent to predicate components. Compliance with LAL testing requirements for orthopedic implants was also confirmed.

Technological Characteristics

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Features femoral stems in various sizes. Materials include porous coating. Designed for uncemented fixation. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, or revision of failed hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Klassic HD® Hip System (K100445)
• Klassic HD® Hip System (K151440)

Submission Summary (Full Text)

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

July 24, 2017

Image /page/0/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the head to the bottom of the chin. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

Total Joint Othopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106

Re: K171962

Trade/Device Name: Klassic HD® Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL, LZO Dated: June 29, 2017 Received: June 30, 2017

Dear Chris 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 (21 CFR

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

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

# Mark N. Melkerson -S

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

Enclosure

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

## Indications for Use

510(k) Number (if known)

#### K171962

Device Name Klassic HD® Hip System

#### Indications for Use (Describe)

The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following:

- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- · Patients who require a total hip replacement.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## 510(k) Summary

| Manufacturer: | Total Joint Orthopedics, Inc.<br>1567 E. Stratford Avenue<br>Salt Lake City, UT 84106<br>Phone: [phone]<br>Fax: [phone] |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber<br>Product Development, Regulatory Manager |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 29, 2017 |
| Device Trade Name: | Klassic HD® Hip System |
| Common Name: | Femoral Hip Stem |
| Classifications: | 21 CFR 888.3358 - Hip joint metal/polymer/metal semi<br>constrained porous-coated uncemented prosthesis |
| | 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi<br>constrained cemented or nonporous uncemented prosthesis |
| | Class II |
| Product Codes: | LPH, LZO, MBL |

## Indications for Use:

The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:

- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular ● necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement. ●

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

## Device Description:

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.

### Predicate Devices:

The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System (K100445, K151440) with respect to indications, design, materials and function. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met the pre-determined acceptance criteria for the verification activities.

### Substantial Equivalence:

The company performed worst case fatigue testing of the Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems, as well as porous coating characterization. The fatigue and characterization results demonstrated that the modified stems are substantially equivalent to the predicate components. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.