GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00

K043346 · Genesis Medical LLC · KWS · Jan 31, 2005 · Orthopedic

Device Facts

• Record ID: K043346
• Device Name: GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
• Applicant: Genesis Medical LLC
• Product Code: KWS · Orthopedic
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasy are not acceptable (e.g., revision a failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.

Device Story

Genesis Total Shoulder Replacement; semi-constrained, cemented shoulder prosthesis. Components: humeral stem (titanium 6-Al-4V alloy, corundum blasted surface, lateral fins for soft tissue); humeral head (cobalt chromium alloy, 6-degree taper, multiple diameters, 4mm offset option); glenoid component (ultra-high molecular-weight polyethylene, pear-shaped, 3-peg fixation, keeled undersurface). Used in orthopedic surgery for total or hemi-shoulder arthroplasty. Surgeon implants device to replace damaged articular surfaces, restore joint stability, and alleviate pain. Design features anatomical neck/shaft angle and oversized glenoid radius of curvature to accommodate various humeral head sizes and facilitate soft tissue balancing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium 6-Al-4V alloy (humeral stem), cobalt chromium alloy (humeral head), ultra-high molecular-weight polyethylene (glenoid). Design: Semi-constrained, cemented, 3-peg glenoid fixation, 6-degree taper interface. Sterilization: Not specified.

Indications for Use

Indicated for patients with severely painful/disabled shoulder joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with comminution or vascular compromise; revision of failed primary components; ununited humeral head fractures; and 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 Select
• Biomet Bio-Modular total shoulder
• Tornier Aequalis
• Global Total Shoulder
• Solar shoulder system

Submission Summary (Full Text)

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## JAN 3 1 2005 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

The following 510(k) Summary of Safety and Effectiveness information is provided in accordance with the requirements of 21 CFR 807.92 and SMDA 1990.

## 510(k) Number: K043346

Date: January 26, 2005

Applicant: Genesis Medical LLC

2650 US Highway 130, Cranbury, NJ 08512 Address:

Contact Person: Perry Geremakis

Phone number: 609 409-3316

Fax number: 609 409 3317

Genesis Total Shoulder Replacement Trade Name:

Common Name: Shoulder prosthesis

Classification Name: Prosthesis, shoulder, semiconstrained, metal/polymer, cemented

Device Description: The humeral stem is manufactured from titanium 6-Al-4V alloy and has a corundum blasted surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. There is a 6 degree male taper to mate with humeral heads. The devices features an anatomical neck/shaft angle. The humeral head is fabricated from cobalt chromium alloy. The head has a low profile and manufactured with a 6 degree taper to mate with the humeral stem. There are numerous head diameters to accommodate anatomical patient variations. An offset head at 4 mm is also available to permit soft tissue balancing and to enhance joint stability. The glenoid component is fabricated from ultra-high molecular-weight polyethylene. It is designed with a pear shaped frontal profile for anatomical fit to the glenoid which avoids soft tissue impingement. The articular surface radius of curvature is oversized to the humeral heads to accommodate multiple humeral head sizes. The device is designed with 3 peg fixation. The pegs are co-linear to help avoid punch through of thin cortical walls at the outer edges of the glenoid. The undersurface is keeled to enhance bone cement fixation.

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KA33-4L

2012

Intended Use: The device is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasy are not acceptable (e.g., revision a failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.

Predicate Devices: Substantial equivalence is derived from a composite of characteristics from multiple predicate devices including the Zimmer Select, the Biomet Bio-Modular total shoulder, Tornier Aequalis, the Global Total Shoulder and the Solar shoulder system.

Technological Characteristics: The Genesis Total Shoulder replacement has similar intended use, design intent, dimensions, surgical technique, materials, biocompatibility and labeling as that of predicate devices. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Mr. Perry A. Geremakis President, Chief Executive Officer Genesis Medical L.L.C 32 Iron Horse Rd Oakland, New Jersey 07436

Re: K043346

Trade/Device Name: Genesis Total Shoulder Replacement Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: November 30, 2004 Received: December 6, 2004

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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, FLJA may publish further announcements concerning your device in the Federal Register.

Plcase 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); 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.

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Page 2 - Mr. Perry A. Geremakis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Genesis Total Shoulder Replacement

Indications for Use:

Total shoulder or hemi-shoulder replacement is indicated for:

- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or 3. resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.

Prescription Use X (21 CFR Part 801 Subpart D) And/or

Over-the-Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number. K043346