(258 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its material properties and performance testing. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is described as an orthopedic implant intended to replace the articular surface of the existing femoral head, which directly treats painful hip arthritis.
No
The device is described as an orthopedic implant intended to replace the articular surface of the existing femoral head, treating painful hip arthritis/arthroplasty. Its function is to replace, not to diagnose.
No
The device description clearly indicates it is a physical orthopedic implant made of Ti-6Al-4V alloy with a Titanium Nitride coating, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant for treating painful hip arthritis and painful hip arthroplasty. It is a physical component intended to be surgically implanted into the body.
- Device Description: The description details a physical orthopedic implant made of metal alloys and coatings, designed to replace a part of the femoral head.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically tests, reagents, instruments, or systems used in vitro (outside the body).
This device is an orthopedic implant, specifically a femoral resurfacing component.
N/A
Intended Use / Indications for Use
The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.
Product codes
KXA
Device Description
The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm.
The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating.
The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral Head
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
Performance testing was conducted to provide support for establishing substantial equivalence. This testing included the following:
- TiN coating characterization; adhesion testing, thickness, hardness, scratch testing
- -CP Ti porous coating characterization; Tensile strength, shear strength, porosity
- Mode 1 wear testing
- -Abrasion resistance testing
- ISO 1143 Rotating beam fatigue testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.
0
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January 19, 2021
BioCore9 LLC Steve Peoples Consultant 9 Whippany Road, BLDG A1, Unit 12 A Whippany, New Jersey 07981
Re: K201219
Trade/Device Name: Biocore9 Femoral Head Resurfacing Component Regulation Number: 21 CFR 888.3400 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Resurfacing Prosthesis Regulatory Class: Class II Product Code: KXA Dated: December 21, 2020 Received: December 22, 2020
Dear Steve Peoples:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi 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) K201219
Device Name Biocore9 Femoral Resurfacing Head Component
Indications for Use (Describe)
The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.
| 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) |
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Biocore9, LLC. Femoral Resurfacing Head Component Traditional 510(k)
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Femoral Resurfacing Head Component.
| Submitted by: | Biocore9, LLC.
9 Whippany Road, Bldg A1, Unit 12.
Whippany NJ 0798
(973)-585-4281 |
|------------------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Stephen J. Peoples |
| | Email: speoplesVMD@gmail.com |
| Proprietary Name: | Biocore9 Femoral Resurfacing Head
Component |
| Common Name: | Femoral Resurfacing Head |
| Classification Name and Reference: | 21 CFR 888.3400, Class II
Hip joint femoral (hemi-hip) metallic
resurfacing prosthesis |
| Device Product Code, Device Panel: | KXA |
| Predicate Device: | Endotec Inc. Modified New Jersey
Femoral Hip Resurfacing Component
510(k) #K904870 |
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Image /page/4/Picture/1 description: The image shows the logo for BIOCORE9. The logo is in blue and features the word "BIOCORE9" in a stylized font. The "O" in "BIOCORE" is replaced by a circular symbol with a gear-like design in the center. The overall design is modern and professional.
Device Description
The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm.
The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating.
The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.
Indications for Use
The Biocore9 Femoral Resurfacing Head Component, used with cement, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.
Substantial Equivalence
Biocore9 Femoral Resurfacing Head Component is substantially equivalent to the Endotec - Modified New Jersey Femoral Hip Resurfacing Component - K904870, since there are no significant differences in materials, form, fit, or functionality. See Table 1 for reference:
Performance Testing
Performance testing was conducted to provide support for establishing substantial equivalence. This testing included the following:
- TiN coating characterization; adhesion testing, thickness, hardness, scratch testing -
- -CP Ti porous coating characterization; Tensile strength, shear strength, porosity
- Mode 1 wear testing -
- -Abrasion resistance testing
- ISO 1143 Rotating beam fatigue testing -
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Table 1: Device Comparison Summary.
| Device | Predicate:
Endotec - Modified New Jersey Femoral
Hip Resurfacing Component - K904870 | Biocore9 Femoral Resurfacing Head
Component |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Component is Axisymmetric with a
truncated spherical shell with central
tapered stem and porous coated inner
surface. Available in several sizes. | Component is Axisymmetric with a
truncated spherical shell with central
tapered stem and porous coated inner
surface. Available in several sizes. |
| Materials | Titanium alloy (ASTM F-136) with
Ultracoat TiN Ceramic coating,
Biocoat® porous coating on the non-
articulating, inner surface. | Titanium alloy (ASTM F-136) with TiN
Ceramic coating, components are porous
coated on the non-articulating, inner
surface. |
| Indications | The Endotec Modified New Jersey
Femoral Hip Resurfacing Component is
intended to treat painful hip arthritis due
to post-traumatic arthritis, osteoarthritis,
or rheumatoid arthritis, as well as hip cup
arthroplasty when sufficient femoral head
and neck stock exist to stabilize a
resurfacing femoral head. | The Biocore9 Femoral Resurfacing Head
Component, used with cement, is indicated
for the treatment of painful hip arthritis due
to post-traumatic arthritis, osteoarthritis, or
rheumatoid arthritis, as well as painful hip
arthroplasty when sufficient femoral head
and neck stock exist to stabilize a
resurfacing femoral head. The Biocore9
Femoral Resurfacing Head Component is
intended for cemented use only. This device
is intended for hemi-arthroplasty only. |
| Size availability | 36.5, 38, 39.5, 41,42.5, 44, 45.5, 47, 49,
51, 52.5 (mm) | 39.5, 41,42.5, 44, 45.5, 47, 49, 51, 52.5
(mm) |
| Anatomical Site | Femoral Head | Femoral Head |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
| 510(K) Number | K904870 | K201219 |