Biocore9 Humeral Resurfacing System

K193122 · Biocore9, LLC · HSD · May 15, 2020 · Orthopedic

Device Facts

• Record ID: K193122
• Device Name: Biocore9 Humeral Resurfacing System
• Applicant: Biocore9, LLC
• Product Code: HSD · Orthopedic
• Decision Date: May 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Non-constrained orthopedic implant; replaces articular surface of humeral head. Axisymmetric truncated shell with tapered central stem; manufactured from Ti-6Al-4V alloy with Titanium Nitride (TiN) ceramic coating. Internal surface features porous titanium bead coating for cemented fixation. Available in five sizes (40-56 mm diameters). Used by orthopedic surgeons in clinical settings for hemi-arthroplasty. Device articulates with natural glenoid; restores joint function in patients with osteoarthritis or rheumatoid arthritis. Benefits include pain relief and improved joint mobility.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical performance testing, including porous coating characterization (tensile strength, shear strength, porosity) and TiN coating evaluation (thickness, adhesion, abrasion resistance, and wear resistance).

Technological Characteristics

Material: Ti-6Al-4V alloy (ASTM F136-13) with Titanium Nitride (TiN) ceramic coating. Design: Axisymmetric truncated shell with tapered central stem. Fixation: Porous titanium bead coating (cemented use only). Sizes: 40-56 mm diameters. Energy source: None (mechanical implant).

Indications for Use

Indicated for patients with painful or severely disabled shoulder joints due to osteoarthritis or rheumatoid arthritis requiring hemi-arthroplasty. Requires sufficient humeral bone stock and intact or reconstructable rotator cuff. Contraindicated for cases without sufficient bone stock or rotator cuff integrity.

Regulatory Classification

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.

Predicate Devices

• Buechel-Pappas, Humeral Head Resurfacing Component (K992394)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.<br>9 Whippany Road, Bldg A1, Unit 12.<br>Whippany NJ 07981 |
|------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | Stephen J. Peoples, VMD, MS, FAOA |
| | Email: [e-mail] |
| Proprietary Name: | Biocore9 Humeral Resurfacing<br>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<br>Resurfacing Component 510(k)<br>#K992394 |

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# 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.