SEVIIN SURFACE REPLACEMENT SHOULDER

K130635 · Ingen Orthopedics, LLC · HSD · Aug 26, 2013 · Orthopedic

Device Facts

• Record ID: K130635
• Device Name: SEVIIN SURFACE REPLACEMENT SHOULDER
• Applicant: Ingen Orthopedics, LLC
• Product Code: HSD · Orthopedic
• Decision Date: Aug 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by: - Rheumatoid arthritis . - Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) . - Correction of functional deformity . - Humeral head fractures . ● - Traumatic arthritis . The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

Device Story

SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis. It consists of a Co-Cr-Mo alloy humeral head (42mm, 48mm, 52mm) with a titanium plasma-sprayed inner surface and a tapered, fluted stem. Designed for patients with sufficient bone stock and intact/reconstructable rotator cuff; requires minimal bone resection compared to traditional total shoulder designs. Can be revised to a longer-stemmed total shoulder if necessary. Used in clinical settings by orthopedic surgeons. Provides an alternative to traditional total shoulder arthroplasty by preserving more bone. Humeral heads are for cemented or uncemented use; glenoid components (compatible with K043346) are for cemented use only.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including torsional testing of humeral head fixation.

Technological Characteristics

Materials: Co-Cr-Mo alloy (ASTM F799) with titanium plasma spray coating. Design: Spherical humeral head with tapered, fluted stem. Sizes: 42mm, 48mm, 52mm. Application: Cemented or uncemented (humeral head); cemented only (glenoid).

Indications for Use

Indicated for patients requiring hemi or total shoulder replacement with sufficient humeral bone stock and intact/reconstructable rotator cuff. Used for severe pain or disability due to rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, or traumatic arthritis.

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

• Copeland MB Resurfacing Humeral Heads (K010657)
• Tornier Aequalis Resurfacing Head (K062661)

Reference Devices

• SEVIIN Total Shoulder Glenoids (K043346)

Submission Summary (Full Text)

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| 510(k) Summary | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared: | March 8, 2013 |
| Submitter: | Ingen Orthopedics, LLC<br>2650 US Highway 130<br>Cranbury, NJ 08512 |
| Contact: | Perry A. Geremakis<br>President, Chief Executive Officer<br>Ingen Orthopedics, LLC<br>P: 609/409-3316<br>F: 609/409-3317<br>E: [e-mail] |
| Proprietary Name: | SEVIIN Surface Replacement Shoulder |
| Common Name: | Resurfacing Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis; Class II<br>21 CFR 888.3660: Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis; Class II |
| Product Codes: | HSD, KWS, KWT |
| Substantially<br>Equivalent Devices: | Copeland MB Resurfacing Humeral Heads, K010657,<br>cleared Sept 14, 2001<br>Tornier Aequalis Resurfacing Head, K062661, cleared<br>December 22, 2006 |
| | AUG 2 6 2013 |

# Device Description:

The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary.

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The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus.

The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.

### Intended Use / Indications:

The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.

Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:

- Rheumatoid arthritis .
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity .
- Humeral head fractures . ●
- Traumatic arthritis .

The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

### Summary of Technologies/Substantial Equivalence:

The SEVIIN Surface Replacement Shoulder is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

### Non-Clinical Testing:

Substantial equivalence analysis and torsional testing of the Resurfacing Humeral Head fixation indicate that all components are adequate for their intended use. Substantial equivalence was based on a comparison of intended use, indications, materials, sizes and design.

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# Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the SEVIIN Surface Replacement Shoulder to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ci609 Silver Spring, MI) 20993-0002

August 26, 2013

Ingen Orthopedics, LLC % Mr. Perry Geremakis President. Chief Executive Officer 2650 US Highway 130 Cranbury, New Jersey 08512

Re: K130635

Trade/Device Name: SEVIIN Surface Replacement Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (heni-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, KWS, KWS, KWT Dated: June 26, 2013 Received: July 18, 2013

Dear Mr. Geremakis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 complics 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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### Page 2 -- Mr. Perry Geremakis

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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K130635

Indications for Use

K130635 510(k) Number (if known): _

Device Name: SEVIIN Surface Replacement Shoulder

Indications for Use:

The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.

Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:

- . Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity ◆
- Humeral head fractures .
- Traumatic arthritis .

The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

Over-The-Counter Use Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

**Casey L. Hanley, Ph.D.**

Division of Orthopedic Devices