TOTAL AND HEMI SHOULDER SYSTEM

K060988 · Dvo Extremity Solutions, LLC · KWS · Dec 6, 2006 · Orthopedic

Device Facts

• Record ID: K060988
• Device Name: TOTAL AND HEMI SHOULDER SYSTEM
• Applicant: Dvo Extremity Solutions, LLC
• Product Code: KWS · Orthopedic
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DVO™ Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.

Device Story

Modular total and hemi shoulder prosthesis system; includes humeral stems, humeral heads (standard/eccentric), and glenoids (pegged/keeled). Humeral heads mate to stems via locking taper. Stems available in standard/long lengths, fluted, with fins/suture holes. Used by orthopedic surgeons in clinical/surgical settings for shoulder arthroplasty. Provides mechanical replacement of the glenohumeral joint to restore function and reduce pain in patients with degenerative or traumatic joint disease. Output is a physical implant system; clinical decision-making relies on surgeon assessment of joint pathology and bone quality. Benefits include joint pain relief and improved mobility.

Clinical Evidence

Bench testing only. Evidence includes dimensional analysis and mechanical strength testing (fatigue load-carrying capability) to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Modular shoulder prosthesis. Materials: titanium alloy (stems), cobalt chrome alloy (heads), UHMWPE (glenoids). Design: humeral stem with locking taper, fluted geometry, fins with suture holes. Configurations: standard/long stems, standard/eccentric heads, pegged/keeled glenoids. Sterilization: gamma irradiation. Mechanical fixation: press-fit or cemented (stems), cemented (glenoids).

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture/dislocations with severe comminution or vascular compromise; or difficult clinical scenarios where arthrodesis/resection are unacceptable (e.g., revision). Hemi-shoulder replacement is also indicated for ununited humeral head fractures, avascular necrosis, and rotator cuff tear arthropathy. Stems/glenoids labeled 'for cemented use only' require bone cement; other stems allow press-fit or cemented use. Single use only.

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

• DePuy Global shoulder system (Total Shoulder, K905786, K914000)
• Advantage Shoulder Humeral Stem and Eccentric Head (K992065)

Submission Summary (Full Text)

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K060988 page 143

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DEC - 6 2006

| Extremity Solutions<br>720 E. Winona Ave., Warsaw, IN 46580 | 510(k) Summary of Safety and Effectiveness |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY PREPARED: | 28 NOVEMBER 2006 |
| 510(k) SPONSOR/APPLICANT: | DVO TM Extremity Solutions, LLC<br>720 E. Winona Ave., Warsaw IN 46580 |
| 510(k) PREPARER and<br>CONTACT PERSON: | Dina L. Weissman, J.D.<br>P.O. Box 205, Derby CT 06418<br>Tel: [phone], Email: [e-mail] |
| TRADE NAME: | Total and Hemi Shoulder System |
| COMMON NAMES: | Shoulder prosthesis, humeral head |
| CLASSIFICATION, CLASS and<br>DEVICE PRODUCT CODE: | 21 CFR 888.3660 Class II, 87 KWS<br>21 CFR 888.3690, Class II, 87 HSD |
| PREDICATE DEVICES: | The DePuy Global shoulder system cleared in:<br>• Total Shoulder, K905786, K914000<br>• Advantage Shoulder Humeral Stem and Eccentric Head, K992065 |

#### DEVICE DESCRIPTION:

This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.

The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).

Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.

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# 510(k) Summary of Safety and Effectiveness

### INTENDED USE:

The DVOTM Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.

### INDICATIONS FOR USE:

The DVO™ Total and Hemi Shoulder System is indicated for:

- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or: 1. rheumatoid arthritis:
- 2. Fracture/dislocations of the proximal humeru:) 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;
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary : omponent).

Hemi-shoulder replacement is also indicated for:

- Ununited humeral head fractures; 1.
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

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# 510(k) Summary of Safety and Effectiveness

### COMPARISON TO PREDICATES:

The DVO Total and Hemi Shoulder System is similar to the listed predicate devices in intended use for total or hemi shoulder replacement, performance characteristics, materials of construction (titanum alloy, cobalt chrome alloy and UHMWPE), methods of sterilization (gamma irradiation), packaging, manufacturing methods and design. This is evidenced by comparison of technological characteristics, dimensional analysis and nonclinical testing.

Specifically, both the DVO subject devices and the Dr.Puy predicate devices are comprised of a humeral stem and a humeral head mating together with an articulating UHMWPE glenoved. The locking tapers for the head and stem are similar in both the subject and predicate systems,

The stems of both systems are offered in similar lengths (standard and long), with similar diameters. The stems are also similar in being tapered, fluted and having fins with suture holes,

The heads of both systems are of similar size and shape and are offered in standard or eccentric styles. Curvature sizes range from 40mm to 56mm with head heights of 15mm, 18mm and 21 coven

The UHMWPE glenoids of both systems are offer in both pegged and keeled configurations.

The systems also share equal indications for use.

From the standpoint of strength analysis, the subject @rvice is substantially equivalent to the predicate stems because its fatigue load carrying capability exceeds the predicate devices.

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DEC - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DVO Extremity Solutions, LLC % Ms. Dina L. Weissman, J.D. P.O. Box 205 Derby. Connecticut 06418

Re: K060988

Trade/Device Name: DVOTM Total and Hemi 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, HSD Dated: November 29, 2006 Received: December 1, 2006

Dear Ms. Weissman:

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 commercc 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, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Dina L. Weissman, J.D.

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" (21 CFR 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 vours.

Barbara Buehler

Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060988

#### Indications for Use

510(k) Number (if known): K060988

Device Name: DVOTM Total and Hemi Shoulder System

Indications for Use: The DVO™ Total and Hemi Sl»vulder System is indicated for:

- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
- Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.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.
- 3. Rotator cuff tear arthropathy.

Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.

This is a single use device.

Prescription Use XXXXXX Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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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Sarbaue Bosens Armson
Division Sign. Off.

Division of Ger Compt 11:10:00 and Neurological Device

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510(k) Number Kolo0988