(128 days)
No
The document describes a hip replacement system and its components, focusing on materials, intended use, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
Explanation: The device, a Hip System, is intended for procedures like correction of functional deformity, and treatment of non-union, fractures, and rheumatoid arthritis, which aim to alleviate or cure a disease or condition.
No
Explanation: The provided text describes a hip replacement system, focusing on its components, intended uses for joint replacement (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis), and testing for performance (e.g., fatigue tests, ROM analysis). There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly indicates it is a hip replacement system consisting of multiple physical components (acetabular shells, liners, stems, heads), not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a hip replacement system used for surgical implantation to treat various conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details components of a hip replacement system (acetabular shells, femoral stems, femoral heads, bipolar heads). These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
The device is a surgical implant for hip replacement.
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; and
- Revision procedures where other treatment or devices have failed.
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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
- The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
- The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
• The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
· The KYOCERA Initia 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)
OQG, LPH, LZO, OQI
Device Description
The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:
- K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System .
- 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 known as Kyocera Corporation) that may be used with the K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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)
All changes were assessed for risk and successfully evaluated under Design Controls. The following were successfully conducted:
- . Static compression burst test
- Post-fatigue static compression burst test ●
- Oblique (off-axis) fatigue test ●
- Pull-off tests
- Static torsion tests ●
- Stem fatigue test ●
- Head neck fatigue test
- ROM analysis ●
- Impingement analysis ●
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Kyocera Medical Technologies, Inc. % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland, Massachusetts 01721
Re: K203472
Trade/Device Name: KMTI Hip Replacement 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: March 29, 2021 Received: March 31, 2021
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.
1
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 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.
for
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203472
Device Name KMTI Hip Replacement 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; and
-
Revision procedures where other treatment or devices have failed.
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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
- The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
- The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
• The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
· The KYOCERA Initia 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
QKAOCERA
Special 510(k) Premarket Notification Summary as required by 21 CFR 807.92(a) K203472
| 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 Medical Technologies, Inc. (“KMTI”) Hip Replacement
System which includes: |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------|
| • KMTI Tesera Trabecular Technologies (T3) Acetabular Shell | |
- KMTI Tesera Trabecular Technologies (T3) Acetabular Shell . System
- . KMTI Porous Acetabular Cup System
Class II Device Class:
- Regulation: 21 CFR 888.3358
- Product Code: OQG, LPH, LZO, OQI
Classification panel: Orthopedic
| C) Predicates: Primary: | K132312 Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System |
|---|---|
| Secondary: | K141676 Renovis Porous Acetabular Cup System |
| Reference device: | K200709 Kyocera Bipolar Hip System |
- 3/31/2021 D) Date Prepared:
4
E) Device Description:
The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:
- K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System .
- 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 known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.
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; and
-
- 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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or . BIOCERAM AZUL (28-40mm) femoral head.
- . The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
5
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 KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
- The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or ● BIOLOX® delta (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
- . The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
- . The KYOCERA Initia 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. Fret corrosion risk was assessed by comparison to K200709 Kyocera Bipolar Hip System (reference device), femoral head and femoral stem design attribute data analysis and rationale, and literature references. Equivalence of the use of KYOCERA components and use of KMTI components has been demonstrated.
H) Compliance with Design Controls
All changes were assessed for risk and successfully evaluated under Design Controls. The following were successfully conducted:
- . Static compression burst test
- Post-fatigue static compression burst test ●
- Oblique (off-axis) fatigue test ●
- Pull-off tests
- Static torsion tests ●
- Stem fatigue test ●
- Head neck fatigue test
- ROM analysis ●
- Impingement analysis ●
6
I) Compliance with Standards or FDA Guidance
- ISO 7206-4:2010/AMD 1:2016 Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components — Amendment 1
- ISO 7206-6:2013 Implants for surgery Partial and total hip joint prostheses -● Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
- ISO 7206-10:2018 Implants for surgery Partial and total hip-joint prostheses -● Part 10: Determination of resistance to static load of modular femoral heads
- ISO 7206-13: 2016 Implants for surgery Partial and total hip joint prostheses -● Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
- . ASTM F2009 (2011) Standard Test Method for Determining the Axial Disassemblv Force of Taper Connections of Modular Protheses
- ASTM F2345-03(2013) Standard Test Methods for Determination of Static and ● Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- Guidance Document For The Preparation Of Premarket Notification For Ceramic . Ball Hip Systems, Draft, January 10, 1995
Conclusion
The performance of the KMTI BIOLOX delta and CoCr femoral heads mated with the KYOCERA Initia femoral stem and used with the KMTI T3 acetabular shell or Porous acetabular shell and Universal Liner is substantially equivalent to and expected to have equivalent performance to the KMTI femoral head/femoral stem used with the KMTI T3 acetabular shell and Porous acetabular cup and Universal Liner.