NOVATION 12/14 PRESS-FIT FEMORAL STEM

K042842 · Exactech, Inc. · LZO · Nov 9, 2004 · Orthopedic

Device Facts

• Record ID: K042842
• Device Name: NOVATION 12/14 PRESS-FIT FEMORAL STEM
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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. Novation® press-fit femoral stems are intended for press-fit fixation. Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Device Story

The Novation 12/14 Press-Fit Femoral Stem is a prosthetic hip component designed for implantation into the femur. It functions as a replacement for the femoral head and neck, providing a structural interface for hip joint reconstruction. The device is intended for press-fit fixation within the femoral canal, though non-HA coated versions may be used with bone cement at the surgeon's discretion. It is used by orthopedic surgeons in a clinical/surgical setting. The device features a circulo-trapezoidal cross-section, a 12/14 taper for head attachment, and is available in various sizes with standard or extended offsets. A distally splined model is included. The device restores joint mobility and addresses degenerative conditions or fractures. It is manufactured from titanium alloy with plasma spray and hydroxyapatite coating.

Clinical Evidence

Bench testing only. Evidence includes ISO 7206-8 empirical fatigue testing and engineering analyses to verify the safety and performance of the modified femoral stem design compared to the predicate device.

Technological Characteristics

Materials: Titanium alloy, commercially pure titanium plasma spray, hydroxyapatite coating. Design: Circulo-trapezoidal cross-section, 12/14 femoral head taper, angled neck flat geometry. Sterilization: Gamma radiation (SAL 10^-6). Shelf life: 5 years. Standards: ISO 7206-8 (fatigue testing).

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, and revision of failed reconstructions with sufficient bone stock.

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

• AcuMatch P-Series Plasma Press-Fit Femoral Stems (K041906)

Submission Summary (Full Text)

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K042842

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招聘, 房 日报 FAX [phone]

# Exactech® Novation 12/14 Press-Fit Femoral Stems

NOV - 9 2004

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

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

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

FDA Establishment Number 1038671

Gary J. Miller Contact: Exec. V.P. of Research & Development

October 7, 2004 Date:

Rev. 10/07/ 04

Section 4 Page 1 of 3

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K042842

### Exactech® Novation 12/14 Press-Fit Femoral Stems

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

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

Novation 12/14 Press-Fit Plasma Femoral Stems

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

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|--------------------------------------------------|----------------|
| #K041906 | AcuMatch P-Series Plasma 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.

Novation® press-fit femoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

#### Device Description:

The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.

The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.

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042842

## Exactech® Novation 12/14 Press-Fit Femoral Stems

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

The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:

- the same indications for use, .
- similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
- the same materials (titanium alloy, commercially pure titanium plasma spray and . hydroxyapatite coating)
- the same shelf life (5 years), and .
- are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level (SAL) of 10").

This Special 510(k) application supports the following design changes:

- The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
- A change to the sizing range and differential. .
- A distally "splined" model was added to the product line. .
- Change in plasma coating application area. .

#### Substantial Equivalency Conclusion:

A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design. Based on successful completion of design control activities for the Exactech Novation 12/14 Press-Fit Plasma Femoral Stems, we propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906. Supporting verification activities include ISO 7206-8 empirical fatigue testing and engineering analyses.

Rev. 10/07/ 04

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Gary J. Miller, Ph.D. Executive Vice President of Research & Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K042842

Trade/Device Name: Novation 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis, Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II

Product Code: LZO, MEH, LWJ, JDI Dated: October 8, 2004 Received: October 14, 2004

Dear Dr. Miller:

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 for associated in the 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 r ou may, aron's reversions 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 If your de rise 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 - Gary J. Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse of substantial equivalence of your device to a legally promance hoticated on "ceresults 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 If you desire specific arrivance 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 other golleral milermational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mellman

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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**Exactech**

2320 NW 6611 1 OUt GAINI:SVILLE, FL 326

52 377 1140 FAX [phone]

# Exactech®, Inc.

### Indications for Use

510(k) Number (if known):

0428y_

Device Name:

Novation 12/14 Press-Fit Femoral Stems

# INDICATIONS FOR USE:

All Exactech Hip Systems are indicated for use in skeletally mature individuals i the Endiven in the 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 notentially 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.

Novation® press-fit femoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

| Prescription Use (Part 21 CFR 801 Subpart D) | X | 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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| Rev. 10/04/04 | 510(k) Number | K042842<br>K042842 | Section 3 Page 1 of 1 |
|---------------|---------------|--------------------|-----------------------|
|---------------|---------------|--------------------|-----------------------|

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