K Number
K193122
Device Name
Biocore9 Humeral Resurfacing System
Manufacturer
Date Cleared
2020-05-15

(185 days)

Product Code
Regulation Number
888.3690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only. The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder ioints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.
Device Description
The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments. The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.
More Information

Not Found

No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device is described as an orthopedic implant intended for the "reconstruction of painful and/or severely disabled shoulder joints," which directly addresses and treats a medical condition.

No

The Biocore9 Humeral Head Resurfacing Shoulder Component is an orthopedic implant for joint reconstruction, not a device used to diagnose medical conditions or diseases.

No

The device description clearly describes a physical orthopedic implant made of Ti-6Al-4V alloy with coatings and porous surfaces, intended for surgical implantation. It is not a software-only device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Description: The Biocore9 Humeral Head Resurfacing Shoulder Component is described as a "non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint."
  • Intended Use: The intended use is for the "reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis." This is a surgical intervention, not a diagnostic test performed on a sample.

The device is a physical implant used in surgery, not a tool for analyzing biological samples outside the body.

N/A

Intended Use / Indications for Use

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

Product codes

HSD

Device Description

The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments.

The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid.

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

shoulder joint, humeral head, proximal humerus, glenoid

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

Non-Clinical Performance Testing
Performance testing was conducted in order to provide support in establishing substantial equivalence of technological characteristics.
Testing was conducted for the Porous coating: Tensile strength, Shear strength, Porosity Testing was conducted for the TiN Coating: Thickness, Adhesion Strength to Ti6Al4V substrate, Abrasion resistance, Wear resistance Mode 1

Key Metrics

Not Found

Predicate Device(s)

Buechel-Pappas, Humeral Head Resurfacing Component 510(k) #K992394

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.

0

May 15, 2020

Image /page/0/Picture/1 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 logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Biocore9, LLC. Stephen J. Peoples Official Correspondent 9 Whippany Road. Bldg A1. Unit 12 Whippany, New Jersey 07981

Re: K193122

Trade/Device Name: Biocore9 Humeral Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 12, 2019 Received: November 12, 2019

Dear Stephen J. 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 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: Michael Owens 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) K193122

Device Name Biocore9 Humeral Resurfacing System

Indications for Use (Describe)

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated 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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Image /page/3/Picture/0 description: The image contains the alphanumeric string "K193122". The text is displayed in a simple, sans-serif font. The color of the text is black, and it is set against a plain white background.

Image /page/3/Picture/2 description: The image shows the word "BIOCORES" in a bold, sans-serif font. The letters are a dark blue color. The "O" in "BIOCORES" is stylized with a circular design that has a gear-like pattern in the center.

Biocore9, LLC. Humeral Resurfacing Shoulder System 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 Humeral Resurfacing Shoulder.

| Submitted by: | Biocore9, LLC.
9 Whippany Road, Bldg A1, Unit 12.
Whippany NJ 07981 |
|------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | Stephen J. Peoples, VMD, MS, FAOA |
| | Email: speoplesVMD@gmail.com |
| Proprietary Name: | Biocore9 Humeral Resurfacing
Shoulder |
| Common Name: | Humeral Resurfacing Head |
| Classification Name and Reference: | 21 CFR 888.3690, Class II |
| Device Product Code, Device Panel: | HSD |
| Predicate Device: | Buechel-Pappas, Humeral Head
Resurfacing Component 510(k)
#K992394 |

4

Image /page/4/Picture/0 description: The image shows the word "BIOCORE9" in a stylized, sans-serif font. The letters are a dark blue color. The "O" in "BIOCORE9" is replaced with a gear-like symbol, with a yellow center. The overall design appears to be a logo.

K193122 Page 2/2

Device Description

The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments.

The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid.

The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

Intended Use

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder ioints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

Non-Clinical Performance Testing

Performance testing was conducted in order to provide support in establishing substantial equivalence of technological characteristics.

Testing was conducted for the Porous coating: Tensile strength, Shear strength, Porosity Testing was conducted for the TiN Coating: Thickness, Adhesion Strength to Ti6Al4V substrate, Abrasion resistance, Wear resistance Mode 1

Substantial Equivalence

Biocore9 Humeral Resurfacing Shoulder System is substantially equivalent to the Endotec - Buechel-Pappas Humeral Resurfacing Component - K992394, since there are no significant differences in form, fit, or functionality.