Klassic HD® Hip System

K180929 · Total Joint Orthopedics, Inc. · LZO · May 9, 2018 · Orthopedic

Device Facts

• Record ID: K180929
• Device Name: Klassic HD® Hip System
• Applicant: Total Joint Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: May 9, 2018
• 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 without bone cement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJ): 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 acetabular cups, inserts, and ceramic femoral heads; used by orthopedic surgeons to restore hip joint biomechanics during total hip arthroplasty. Device functions as prosthetic replacement for diseased or failed hip joints. System components are implanted without bone cement. This modification adds smaller sizes of acetabular cups, inserts, and ceramic femoral heads, plus hooded and low-profile inserts using XLPE material. Surgeons select components based on patient anatomy to address pain, deformity, or dysfunction. Benefits include restoration of joint function and mobility. Device is used in surgical settings.

Clinical Evidence

Bench testing only. Testing included burst strength, fatigue, post-fatigue burst strength, and pull-off testing per ISO 7206-10; push-out, lever-out, and axial torque disassembly per ASTM F1820; range of motion per ISO 21535; impingement testing per ASTM F2852; and wear testing per ISO 14242. LAL testing for orthopedic implants performed per AAMI ST-72.

Technological Characteristics

System includes acetabular cups, inserts (XLPE), and ceramic femoral heads. Materials include metal, ceramic, and polymer. Testing standards: ISO 7206-10 (femoral head strength), ASTM F1820 (disassembly), ISO 21535 (ROM), ASTM F2852 (impingement), ISO 14242 (wear), and AAMI ST-72 (LAL). Non-constrained/semi-constrained design for uncemented application.

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 Acetabular Cups with Ti-Coat (K100445)
• Klassic HD® Acetabular Inserts with E-Link® Poly (K141972)
• Klassic HD® Acetabular Inserts with XLPE (K161073)
• Klassic HD® Ceramic Femoral Heads (K143407)
• Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K173104)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

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

May 9, 2018

Re: K180929

Trade/Device Name: Klassic HD® Hip System 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, OOG, MBL, LWJ Dated: April 9, 2018 Received: April 9, 2018

Dear Mr. 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 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 (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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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### Indications for Use

510(k) Number (if known) K180929

Device Name Klassic HD® Hip System

| Indications for Use (Describe) |
|----------------------------------------------|
| The Klassic HD Hip System is intended for... |

- 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 (NIDJ): 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)

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## 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: | May 08, 2018 |
| Device Trade Name: | Klassic HD® Hip System |
| Common Name: | Acetabular Shell, Acetabular Insert, 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-<br>constrained porous-coated uncemented prosthesis<br><br>21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic<br>cemented or uncemented prosthesis.<br><br>Class II |
| Product Codes: | LZO, LPH, OQG, MBL, LWJ |

### 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. ●

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- 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 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 smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.

### Predicate Devices:

The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System Acetabular Cups with Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K173104) with respect to indications, design, materials and function.

### Substantial Equivalence:

Engineering analysis and testing included burst strength testing, fatigue testing, postfatigue burst strength testing and pull off testing of ceramic femoral heads per ISO 7206-10. Analysis and testing also included Push out, lever out, axial torque disassembly per ASTM F1820, Range of Motion per ISO 21535, impingement testing per ASTM F2852 and wear testing per ISO 14242. and all results met the pre-determined acceptance criteria identified in the Design Control Activities. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the pre-determined acceptance criteria for the verification activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.