HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System

K142942 · Arthrosurface, Inc. · HSD · Dec 19, 2014 · Orthopedic

Device Facts

• Record ID: K142942
• Device Name: HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
• Applicant: Arthrosurface, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Device Story

HemiCAP Humeral Head XL (HHXL) is a metallic, uncemented shoulder hemi-arthroplasty implant. System consists of an articular resurfacing component and a taper post fixation component that mate via a taper interlock. Designed for surgical implantation by orthopedic surgeons to replace damaged humeral head surfaces. Provides stable, immobile fixation and stress-bearing contact at the bone/prosthetic interface. Used in clinical settings for patients with post-traumatic degenerative disease or avascular necrosis. Benefits include joint reconstruction and pain relief. Device is single-use and requires bone cement for fixation.

Clinical Evidence

Bench testing only. Non-clinical performance data included static compression testing, cyclic fatigue testing, axial disassembly testing, and torsional testing. Results demonstrated safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Metallic, uncemented humeral hemi-shoulder prosthesis. Features an articular resurfacing component and a taper post fixation component. Employs a taper interlock mechanism for fixation. Single-use implant designed for use with bone cement.

Indications for Use

Indicated for patients requiring reconstruction of painful/severely disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis. Requires sufficient humeral head/neck bone stock and intact or reconstructable rotator cuff. Contraindicated if bone stock is insufficient or rotator cuff is irreparable.

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

• Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096)
• Biomet Inc.'s Copeland Resurfacing Heads (K003044)
• Biomet Inc.'s Copeland Resurfacing Heads (K010664)
• DePuy Orthopaedics Inc.'s Global CAP Resurfacing Replacement Shoulder (K031971)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Arthrosurface Incorporated Ms. Dawn J. Wilson Vice President of Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K142942

Trade/Device Name: HemiCAP Humeral Head XL (HHXL) Articular 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 18, 2014 Received: November 20, 2014

Dear Ms. Wilson:

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. 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 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 4 Indications for Use Statement

510(k) Number (if known):

- HemiCAP® Humeral Head XL (HHXL) Device Name: Articular Resurfacing System
### Indications For Use:

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
|-------------------------------------------------|--------|------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### Section 5 510(k) Summary

## HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System

## Special 510(k): Device Modification

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Tel:<br>508.520.3003<br>508.528.4604<br>Fax: | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory<br>508.520.3003<br>Tel:<br>508.528.4604<br>Fax:<br>[e-mail] | |
| Establishment Registration<br>Number: | 3004154314 | |
| Date of Preparation: | October 9th, 2013 | |
| Confidentiality: | Reference Section 3 | |
| Proprietary Name: | HemiCAP® Humeral Head XL (HHXL)<br>Articular Resurfacing System | |
| Common Name: | Hemi-Shoulder Resurfacing Prosthesis | |
| Device: | Prosthesis, Shoulder, Hemi-, Humeral, Metallic<br>Uncemented | |
| Regulation Description: | Shoulder joint humeral (hemi-shoulder) metallic<br>uncemented prosthesis | |
| Requlation Number: | 888.3690 | |
| Device Class: | Class II | |
| Review Panel: | Orthopedic | |
| Product Code: | HSD | |

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## Intended Use

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

## Device Description

The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

## Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the HemiCAP® Humeral Head XL Articular Resurfacing System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

- . The sponsor's previously cleared Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003)
- Biomet Inc.'s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001)
- DePuy Orthopaedics Inc.'s Global CAP Resurfacing Replacement Shoulder ● (K031971, Cleared on 09/24/2003)

The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K023096).

- Has the same Indications for Use,
- o Has the same operating principle,
- Is manufactured using the same material,
- Has the same shelf life,
- ls packaged and sterilized using the same materials and processes. ●

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In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:

- o Static Compression Testing
- Cyclic Fatigue Testing ●
- . Axial Disassembly Testing
- Torsional Testing .

The results have demonstrated the safety and effectiveness of the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System Implants along with substantial equivalence to the predicate device (K023096).