(30 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques
Qualifier:
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.
-The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.
The Bipolar Head is for uncemented use only.
Bipolar outer heads are not for use with acetabular shells and liners.
The Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:
- K131354: Renovis Bipolar Hip 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 is 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 K131354 Kyocera Bipolar Hip System.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance results, or any study details that would allow me to answer your request.
The document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. It discusses:
- Device name and classification.
- Intended use and indications for use.
- Comparison to a predicate device.
- Compliance with design controls and FDA guidance.
It does not contain any data from performance studies, clinical trials, or validation tests that would outline acceptance criteria and how a device achieved them. Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request for this specific document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.
Kyocera Medical Technologies, Inc. % Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland, Massachusetts 01721
April 17, 2020
Re: K200709
Trade/Device Name: Kyocera Bipolar Hip System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: March 16, 2020 Received: March 18, 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.
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
{1}------------------------------------------------
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 (OS) 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
510(k) Number (if known) K200709
Device Name Kyocera Bipolar Hip System
Indications for Use (Describe)
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Correction of functional deformity;
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques
Qualifier:
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm
CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.
-The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI
22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.
The Bipolar Head is for uncemented use only.
Bipolar outer heads are not for use with acetabular shells and liners.
| 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}------------------------------------------------
KYOCERA
Special 510(k) Premarket Notification Summary as required by 21 CFR 807.92(a) K200709
| A ) Submitted by: | Kyocera Medical Technologies, Inc.1200 California St. Suite 210Redlands, CA 92374Phone: 909-557-2360Fax: 909-839-6269 |
|---|---|
| Official Contact: | Anthony DeBenedictisDivisional Vice President of Quality Assurance |
| Consultant: | Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721 |
- B) Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Proprietary Name: Kyocera Bipolar Hip System
Device Class: Class II
Regulation: 21 CFR 888.3390
Product Code: KWY
Classification panel: Orthopedic
- C) Predicates: Primary: K131354 Renovis Bipolar Hip System
- D) Date Prepared: March 25, 2020
E) Device Description:
The Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:
- K131354: Renovis Bipolar Hip System ●
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San
{4}------------------------------------------------
Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification is 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 K131354 Kyocera Bipolar Hip System.
F) Intended Use/Indications For Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
-
- Rheumatoid arthritis;
-
- Correction of functional deformity;
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Qualifier:
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
- . The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.
- . The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.
The Bipolar Head is for uncemented use only.
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 have been demonstrated.
H) Compliance with Design Controls
All changes were assessed for risk and successfully evaluated under Design Controls.
I) Compliance with Standards or FDA Guidance
This application complies with:
- Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained ● Cemented or Uncemented Prosthesis; Guidance for Industry and FDA, April 29, 2002
- . Non-clinical Information for Femoral Stem Prostheses, September 17, 2007
{5}------------------------------------------------
Conclusion
The KYOCERA Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems used with the KMTI 28mm ID Bipolar Head, and the KYOCERA Initia Total Hip System femoral stem used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head, are substantially equivalent and expected to have equivalent performance when used in place of the corresponding KMTI implants used with the KMTI Bipolar Head.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.