TOTAL SHOULDER SYSTEM

K102670 · Shoulder Innovations, LLC · KWS · Jan 24, 2011 · Orthopedic

Device Facts

• Record ID: K102670
• Device Name: TOTAL SHOULDER SYSTEM
• Applicant: Shoulder Innovations, LLC
• Product Code: KWS · Orthopedic
• Decision Date: Jan 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: - significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - united humeral head fractures of long duration; - irreducible 3- and 4-part proximal humeral fractures; - avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Device Story

Modular shoulder prosthesis system consisting of humeral stems, humeral heads, and glenoid component. Humeral stems (CoCr) feature rotational stability fins with suture holes and collar to resist subsidence; male Morse-type taper interface. Humeral heads (CoCr) available in standard/offset configurations; female Morse-type taper. Glenoid component (UHMWPE) multi-pegged design for cemented fixation. System used by orthopedic surgeons in clinical settings for hemiarthroplasty or total shoulder arthroplasty. Provides structural replacement for diseased or fractured glenohumeral joints; restores joint function and reduces patient disability.

Clinical Evidence

Bench testing only. Glenoid component tested per ASTM F2028 (Dynamic Evaluation of Glenoid Loosening or Disassociation). Modular humeral components tested per ASTM F2009 (Axial Disassembly Force of Taper Connections). No clinical data provided.

Technological Characteristics

Materials: Cobalt Chrome (CoCr) humeral components, Ultra High Molecular Weight Polyethylene (UHMWPE) glenoid component. Design: Modular humeral stems with fins and Morse-type taper; multi-pegged glenoid. Fixation: Cemented (glenoid); press-fit or cement (humeral stem). Standards: ASTM F2028, ASTM F2009.

Indications for Use

Indicated for patients requiring partial or total shoulder arthroplasty due to degenerative, rheumatoid, or traumatic glenohumeral joint disease, united humeral head fractures of long duration, irreducible 3- and 4-part proximal humeral fractures, or avascular necrosis of the humeral head.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Zimmer Bigliani/Flatow Total Shoulder System (K982981)

Submission Summary (Full Text)

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JAN 2 4 2011

## K102670 510(k) Summary Pursuant to 21 CFR 807.92c

Submitted By:

Andrew Rodenhouse Shoulder Innovations, LLC 4670 Fulton St E, Suite 202 Ada, MI 49301 Ph: 616-706-3903 Fax: [phone]

Date:

January 18, 2011

Device Information:

Trade Name: Total Shoulder System

Shoulder Prosthesis Common Name:

- 21 CFR Section 888.3650 Shoulder joint Classification: metal/polymer non-constrained cemented prosthesis. Product Code: KWT 21 CFR Section 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis. Product Code: KWS 21 CFR Section 888.3690 – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Product Code: HSD
Substantially Equivalent Device:

K982981: Zimmer Bigliani/Flatow Total Shoulder System

Image /page/0/Picture/12 description: The image contains a logo and the word "Shoulder Innovation". The logo is a circular arrow pointing downwards, with a smaller arrow pointing upwards inside the circle. The text is located to the right of the logo. The text is in a sans-serif font.

Page 1 of 3

**Total Shoulder System – Updated 1/18/11**
510(k) Premarket Notification

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**CONFIDENTIAL**

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### Device Description:

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.

The glenoid component is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid is a multi-pegged design and intended for cemented fixation only.

Intended Use:

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

- significant disability in degenerative, rheumatoid, or traumatic . disease of the glenohumeral joint;
- united humeral head fractures of long duration; .
- irreducible 3- and 4-part proximal humeral fractures; ●
- avascular necrosis of the humeral head. .

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

oulder System - Updated 1/18/11 market Notification

**Page 5.3**
**CONFIDENTIAL**

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#### Performance Data:

Performance testing was performed on the Shoulder Innovations Total Shoulder System. The glenoid component was tested per ASTM F2028 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. The modular humeral components were tested per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. No clinical testing was performed.

#### Substantial Equivalence:

The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Total Shoulder System is substantially equivalent to the predicate device.

Image /page/2/Picture/5 description: The image contains a circular symbol with an arrow pointing downwards and to the left. To the right of the symbol, the words "Shoulder Innovation" are written in a bold, sans-serif font. The text is aligned horizontally with the symbol, and the overall image appears to be a logo or icon.

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otal Shoulder System - Updated 1/18/1 510(k) Premarket Notification

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

JAN 2 4 2011

Shoulder Innovations. LLC % Mr. Andrew Rodenhouse 4670 Fulton Street East, Suite 202 Ada, Michigan 49301

Re: K102670

Trade/Device Name: Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD Dated: January 12, 2011 Received: January 12, 2011

Dear Mr. Rodenhouse:

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

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Page 2 - Mr. Andrew Rodenhouse

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 forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 A. Milkersen

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

Enclosure

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# Indications for Use Statement

510(k) Number:

KID 2670

Device Name: Total Shoulder System

Indications for Use:

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

- 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- 2. united humeral head fractures of long duration;
- 3. irreducible 3- and 4-part proximal humeral fractures;
- 4. avascular necrosis of the humeral head.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Prescription Use_ × (per CFR 801.109)

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Mulkern

(Division Sign-Off) (Division Sign-Order, Orthopedic, Division of Surgicas Division on one of and Restorative Devices

or

K102670

510(k) Number

Shoulder
Innovations

Shoulder Syster

0(k) Premarket Notification

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**CONFIDENTIAL**