Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

K200328 · Kyocera Medical Technologies, Inc. · OQG · Mar 11, 2020 · Orthopedic

Device Facts

• Record ID: K200328
• Device Name: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
• Applicant: Kyocera Medical Technologies, Inc.
• Product Code: OQG · Orthopedic
• Decision Date: Mar 11, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KMTI Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. Qualifiers: The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem. The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head. The Cemented Hip Stem is intended for cemented applications. The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head. The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

Device Story

Hip replacement system components; includes acetabular shells, liners, femoral stems, and heads. Enables modular assembly of cementless or cemented hip prostheses. Used by orthopedic surgeons in clinical settings for total hip arthroplasty or revision. Device provides structural support and articulation for hip joint; restores joint function; alleviates pain from degenerative disease or trauma. Subject device expands compatibility to include Kyocera Initia femoral stems and CoCr or BIOCERAM AZUL femoral heads.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 21535:2007/Amd 1:2016 and ASTM F1820-13 (disassembly forces) performed to validate modular component compatibility.

Technological Characteristics

Metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Materials include CoCr and BIOCERAM AZUL. Modular design. Standards: ISO 21535:2007/Amd 1:2016, ASTM F1820-13.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), and revision procedures.

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

• Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System (K132312)
• Renovis Porous Acetabular Cup System (K141676)

Reference Devices

• Renovis Surgical Hip Joint Replacement System (K112897)
• Kyocera Medical Corporation Initia Total Hip System (K160895)

Submission Summary (Full Text)

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Kyocera Medical Technologies, Inc. % Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Avenue Ashland, Massachusetts 01721

Re: K200328

Trade/Device Name: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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: OQG, LPH, LZO, OQI Dated: February 6, 2020 Received: February 10, 2020

March 11. 2020

Dear Sharyn Orton:

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.

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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) 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.

Vesa Vuniqi, MS 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

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## Indications for Use

510(k) Number (if known) K200328

Device Name

Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System

Indications for Use (Describe)

The KMTI Hip Replacement System is indicated for patients suffering from:

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- 2. Rheumatoid arthritis;
- 3. Correction of functional deformity;

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and

5. Revision procedures where other treatment or devices have failed.

Oualifiers:

The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.

The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.

The Cemented Hip Stem is intended for cemented applications.

The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

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

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
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| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart C) </span> </span> |

区 Prescription Use (Part 21

The-Counter Use (21 CFR

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# KYOCERA

## Special 510(k) Premarket Notification Summary as required by 21 CFR 807.92(a)

| A ) Submitted by: | Kyocera Medical Technologies, Inc.<br>1200 California St. Suite 210<br>Redlands, CA 92374<br>Phone: [phone]<br>Fax: [phone] |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Anthony DeBenedictis<br>Divisional Vice President of Quality Assurance |
| Consultant: | Sharyn Orton, Ph.D.<br>MEDIcept, Inc.<br>200 Homer Ave<br>Ashland, MA 01721 |

- B) Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

| Proprietary Name: | Kyocera Medical Technologies, Inc. (“KMTI”) Hip Replacement |
|------------------------|-------------------------------------------------------------|
| System which includes: | |

- KMTI Tesera Trabecular Technologies (T3) Acetabular Shell System
- KMTI Porous Acetabular Cup System ●
- Device Class: Class II
- Regulation: 21 CFR 888.3358
- OQG, LPH, LZO, OQI Product Code:

Classification panel: Orthopedic

- C) Predicates: Primary: K132312 Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System Secondary: K141676 Renovis Porous Acetabular Cup System
D) Date Prepared: February 6, 2020

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## E) Device Description:

The Renovis Surgical Hip Joint Replacement System (K112897) includes multiple subsystem offerings, including:

- K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System 0
- K141676: Renovis Porous Acetabular Cup System ●

Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI universal acetabular liners.

- F) Intended Use/Indications For Use:
The KMTI Hip Replacement System is indicated for patients suffering from:

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- 2. Rheumatoid arthritis;
- 3. Correction of functional deformity;
- 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
- 5. Revision procedures where other treatment or devices have failed.

#### Qualifiers:

The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.

The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.

The Cemented Hip Stem is intended for cemented applications.

The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.

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The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

- G) Substantial Equivalence Comparison and Discussion
There is no change in the Intended Use/Indications for Use; no change in implant materials, manufacturing, packaging, and/or sterilization. Equivalence of KCJ components to KMTI components has been demonstrated.

H) Compliance with Design Controls

All changes were assessed for risk and successfully evaluated under Design Controls. Range of Motion analysis was successfully conducted.

I) Compliance with Standards or FDA Guidance

- ISO 21535:2007/Amd 1: 2016 Non-active surgical implants Joint replacement ● implants - Specific requirements for hip-joint replacement implants -Amendment 1
- ASTM F1820-13 Standard Test Methods for Determining the Forces for ● Disassembly of Modular Acetabular Devices

#### Conclusion

The KCJ CoCr or BIOCERAM AZUL femoral head/Initia femoral stem with the KMTI universal liner and T3 acetabular shell or Porous acetabular shell is substantially equivalent and expected to have equivalent performance to the KMTI CoCr or Biolox delta ceramic femoral head/femoral stem with the KMTI universal liner and T3 acetabular shell or Porous acetabular shell.