DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER

K061547 · Wrightmedicaltechnologyinc · LPH · Jul 3, 2006 · Orthopedic

Device Facts

• Record ID: K061547
• Device Name: DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER
• Applicant: Wrightmedicaltechnologyinc
• Product Code: LPH · Orthopedic
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as ostecarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; 2. 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.

Device Story

DYNASTY™ Acetabular System is a hip prosthesis component set consisting of an acetabular shell and liner. Shells are manufactured from cast titanium alloy with a porous-coated sintered bead surface for fixation; liners are manufactured from UHMWPE. The system is intended for use by orthopedic surgeons in total hip arthroplasty procedures to replace damaged hip joints, reduce pain, and improve function. The device provides mechanical support and articulation for the hip joint. No software or algorithmic components are involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Acetabular shell: cast titanium (Ti) alloy with porous-coated Ti alloy sintered beads; 50mm-58mm outer diameter; 3 screw holes for fixation. Acetabular liner: UHMWPE; 32mm-42mm inner diameter. Mechanical hip prosthesis component.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, or revision procedures.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Submission Summary (Full Text)

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Kobl547 pge 192

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL - 3 2006

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the DYNASTY™ Acetabular System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 2, 2006 |
| Contact Person: | Matt Paul<br>Regulatory Affairs Specialist |
| Proprietary Name: | DYNASTY™ Acetabular System |
| Common Name: | Acetabular Shell<br>Acetabular Liner |
| Classification Name and Reference: | 21 CFR 888.3350 Prosthesis, hip, semi-constrained,<br>metal/polymer, cemented - Class II<br>21 CFR 888.3358 Prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/JDI, MBL, LPH |

### DEVICE INFORMATION

### A. Intended Use

The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- non-inflammatory degenerative joint disease such as ostecarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed.

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## B. Device Description

The design features of the DYNASTY™ Acetabular Shell and DYNASTY™ A-CLASS™ Poly Acetabular Liner are summarized below:

- Shells manufactured from cast titanium (Ti) alloy .
- Shells porous coated with Ti alloy sintered beads .
- Shell sizes: 50mm-58mm outer diameter .
- . Shells provide 3 screw holes in a single quadrant for additional fixation
- Liners manufactured from UHMWPE .
- Liner sizes: 32mm-42mm inner diameter �

# C. Substantial Equivalence Information

The indications for use of the DYNASTY™ Acetabular System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Wright Medical Technology, Inc. % Mr. Matt Paul Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K061547

Trade/Device Name: DYNASTYTM Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulation Class: II Product Code: LPH, JDI, MBL Dated: June 2, 2006 Received: June 5. 2006

Dear Mr. Paul:

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. 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

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#### Page 2 - Mr. Matt Paul

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. 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 of 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 the Division of Sinall
240, 276, 2150, and its International and Consumer Assistance at its tollall or 240-276-3150 or at its Internet address http://www.fds.gov/cdrh/industry/support/index.html.

Sincerely yours,

Surbare Buchma
for
M. N. Meller

Mark N. Melkerson 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: DYNASTY™ Acetabular System

Indications For Use:

The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dy splasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
- 4. revision procedures where other treatments or devices have failed

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorativ and Neurological Devices

510(k) Number K101547

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