DYNASTY CERAMIC FEMORAL HEAD

K072656 · Wrightmedicaltechnologyinc · LZO · Feb 6, 2008 · Orthopedic

Device Facts

• Record ID: K072656
• Device Name: DYNASTY CERAMIC FEMORAL HEAD
• Applicant: Wrightmedicaltechnologyinc
• Product Code: LZO · Orthopedic
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• 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 osteoarthritis, 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, - revision procedures where other treatments or devices have failed. 4. The DYNASTYTM Acetabular Shell is for both cemented and uncemented use.

Device Story

The DYNASTY Acetabular System is a hip joint prosthesis used in total hip arthroplasty. It consists of alumina ceramic femoral heads and titanium alloy neck sleeves. The system is designed to replace damaged hip joint components to reduce pain and improve function in patients. It is intended for use by orthopedic surgeons in a clinical/surgical setting. The device functions as a mechanical implant; it does not involve software, algorithms, or electronic data processing. The system supports both cemented and uncemented surgical techniques.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Alumina ceramic (femoral heads), titanium alloy (neck sleeves). Form factor: Femoral heads (28, 32, 36, 38, 40, 42, 46mm OD); neck sleeves (short, medium, long, x-long). Mechanical prosthesis for hip arthroplasty. No software, electronics, or connectivity.

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/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Submission Summary (Full Text)

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K072656

FEB - 6 - 16 - 16

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 use of the DYNASTYTM Acetabular System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 4, 2008 |
| Contact Person: | Matt Paul |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | DYNASTY™ Acetabular System |
| Common Name: | Femoral Head<br>Neck Sleeve |
| Classification Name and Reference: | 21 CFR 888.3353 Hip joint metal/ceramic/ polymer<br>semi-constrained cemented or nonporous<br>uncemented prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/LZO |

### 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 osteoarthritis, 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,
- revision procedures where other treatments or devices have failed. 4.

The DYNASTYTM Acetabular Shell is for both cemented and uncemented use.

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## B. Device Description

The design features of the DYNASTY™ Ceramic Femoral Head and DYNASTY™ Neck Sleeve are summarized below:

- Heads manufactured from Alumina Ceramic .
- Head sizes: 28, 32, 36, 38, 40, 42, 46mm outer diameter .
- Neck sleeves manufactured from Titanium alloy .
- Neck sleeve sizes: short, medium, long, x-long .

## 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 data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

FEB -6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072656 Trade/Device Name: DYNASTY Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: January 4, 2008 Received: January 7, 2008

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 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. Matt Paul

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sincerely yours,

Barbara Buelind

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 DYNASTYTM 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 dysplasia;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis:
- 3. correction of functional deformity; and,
- 4. revision procedures where other treatments or devices have failed

The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.

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)

Barbara Buellm

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K672656

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