BIOLOX CONTOURA Ceramic Femoral Head

K191399 · Total Joint Othopedics, Inc. · LZO · Aug 28, 2019 · Orthopedic

Device Facts

• Record ID: K191399
• Device Name: BIOLOX CONTOURA Ceramic Femoral Head
• Applicant: Total Joint Othopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

BIOLOX CONTOURA Ceramic Femoral Head is a component of the Klassic HD Hip System; used for prosthetic hip replacement. Device restores hip joint biomechanics intra-operatively. Input: surgical requirement for hip arthroplasty. Output: ceramic femoral head (28mm, 36mm diameters, various offsets) articulating within hip prosthesis. Used in clinical/surgical settings by orthopedic surgeons. Benefits: provides durable bearing surface for patients with degenerative/inflammatory joint disease or failed prior surgeries. Device functions as mechanical implant; no software or algorithm involved.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included burst strength, burst fatigue, post-fatigue burst strength, pull-off, and torque disassembly. Engineering analyses evaluated impingement, range of motion, and wear. LAL testing for orthopedic implants performed.

Technological Characteristics

Ceramic femoral head (BIOLOX CONTOURA). Diameters: 28mm, 36mm. Various offsets. Mechanical implant for hip arthroplasty. No software, electronics, or energy source.

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/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Klassic HD Hip System (K100445)
• Klassic HD Hip System (K180929)
• Klassic HD Ceramic Femoral Heads (K143407)

Submission Summary (Full Text)

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

August 28, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

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

### Re: K191399

Trade/Device Name: BIOLOX CONTOURA Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, LPH, MBL, LWJ, OQG Dated: July 29, 2019 Received: July 29, 2019

### 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

### 510(k) Number (if known) K191399

Device Name

BIOLOX CONTOURA® Ceramic Femoral Head

| 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] |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber<br>Product Development, Regulatory Manager |
| Prepared By: | MCRA, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone] |
| Date Prepared: | May 23, 2019 |
| Device Trade Name: | BIOLOX CONTOURA® Ceramic Femoral Head |
| Common Name: | Ceramic Femoral Head |
| Classifications: | 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis<br><br>21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis<br><br>Class II |
| Product Codes: | LZO, LPH, MBL, LWJ, OQG |

## 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 BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.

### Predicate Devices:

The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System (K100445 & K180929), and Klassic HD® Ceramic Femoral Heads (K143407) with respect to indications, design, materials and function. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the predetermined acceptance criteria for the verification activities.

### Substantial Equivalence:

The subject device underwent burst strength testing, burst fatigue testing, post-fatigue burst strength testing, pull-off testing, and torque disassembly testing. In addition, engineering analyses were performed to evaluate the impingement, range of motion and wear of BIOLOX CONTOURA® ceramic femoral heads. Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.