NOVATION SPLINED RDD FEMORAL STEMS

K063279 · Exactech, Inc. · LZO · Nov 29, 2006 · Orthopedic

Device Facts

• Record ID: K063279
• Device Name: NOVATION SPLINED RDD FEMORAL STEMS
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Story

Novation Splined RDD (Reduced Distal Diameter) Femoral Stems are orthopedic implants for hip arthroplasty. Device serves as femoral component in total hip replacement; implanted by surgeons in clinical/OR settings. Modification of predicate Novation 12/14 Splined Press-Fit Femoral Stems; features reduced distal cross-sectional diameter to accommodate anatomical variations. Implanted into femur to restore joint function and mobility. Benefits include improved fit for specific patient anatomy while maintaining established clinical performance of the Novation system.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Femoral stem prosthesis; metallic construction. Features splined geometry with reduced distal diameter. Designed for press-fit fixation. No software or electronic components.

Indications for Use

Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, or proximal femoral fractures. Also indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions with sufficient bone stock, and restoration of mobility after fusion.

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.

Predicate Devices

• Novation 12/14 Press-Fit Femoral Stems (K042842)

Submission Summary (Full Text)

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K063279
NOV 29 2006

## plined RDD Femoral Stems Exactecl

# Special 510(k) - 510(k) Summary of Safety and Effectiveness

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

| Phone: | (352) - 377 - 1140 |
|--------|--------------------|
| Fax: | (352) - 378 - 2617 |

FDA Establishment Number 1038671

- Contact: Maritza Elias Regulatory Representative
Date: October 13, 2006

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## Exactech® Novation Splined RDD Femoral Stems

## Special 510(k) - 510(k) Summary of Safety and Effectiveness

## Trade or proprietary or model name(s):

Novation Splined RDD Femoral Stems

## Information on devices to which substantial equivalence is claimed:

| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|----------|----------------------------------------|----------------|
| Number | | |
| #K042842 | Novation 12/14 Press-Fit Femoral Stems | Exactech, Inc. |

## INDICATIONS FOR USE:

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

- . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- . Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

## Device Description:

The proposed Novation Splined RDD Press-Fit Femoral Stem is a modification of the predicate Novation 12/14 Splined Press-Fit Femoral Stems cleared through premarket notification #K042842. Both products share the same intended use and basic fundamental scientific technology and differ only in the proposed reduced distal crosssectional diameter.

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Exactech® Novation Splined RDD Femoral Stems

# Special 510(k) - 510(k) Summary of Safety and Effectiveness

## Substantial Equivalency Conclusion:

Engineering evaluations were conducted to verify that the performance of the proposed Novation Splined RDD Femoral Stems would be adequate for anticipated in pivo use. Based on successful results discussed in this submission, we conclude the proposed devices are substantially equivalent to Exactech's predicate femoral stems.

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

NOV 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc. c/o Ms. Maritza Elias Regulatory Representative 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K063279

Trade/Device Name: Novation Splined Reduced Distal Diameter (RDD) Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis Regulatory Class: II Product Code: LZO, MEH, LWJ, and JDI Dated: October 13, 2006 Received: October 31, 2006

Dear Ms. Elias:

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

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Page 2 - Ms. Maritza Elias

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. 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,

Barbara Becker

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

Enclosure

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# K063279

## Exactech® Novation Splined RDD Femoral Stems

#### Special 510(k) - Indications for Use

#### 510(k) Number (if known):

Novation Splined RDD Femoral Stems Device Name:

#### INDICATIONS FOR USE:

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

- Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit . applications.

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 - use another page if needed.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Kaubara Buchins

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

Rev 10/13/06

510(k) Number K063279

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