(30 days)
No
The provided text describes a hip replacement system and its components, with no mention of AI or ML technology.
Yes
The device is a Bipolar Head for hip replacement, indicated for treating various joint diseases, fractures, and functional deformities, which directly addresses medical conditions to improve patient health.
No.
The device described is a hip replacement system, specifically a Bipolar Head for use in total hip replacement, which is a therapeutic device, not a diagnostic one.
No
The device description clearly indicates that the device is a Bipolar Head, which is a physical component of a hip replacement system. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a component of a hip replacement system used for treating various joint conditions and fractures. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description clearly states it's part of a "Hip Replacement System" and specifically a "Bipolar Hip System."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
KWY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint / Femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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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)
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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 210
Redlands, CA 92374
Phone: 909-557-2360
Fax: 909-839-6269 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Anthony DeBenedictis
Divisional Vice President of Quality Assurance |
| Consultant: | Sharyn Orton, Ph.D.
MEDIcept, Inc.
200 Homer Ave
Ashland, 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
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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.