NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20

K102487 · Exactech, Inc. · LZO · Nov 8, 2010 · Orthopedic

Device Facts

• Record ID: K102487
• Device Name: NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 8, 2010
• 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

Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are orthopedic implants used in hip arthroplasty. Device serves as femoral component in total or hemi-hip replacement; implanted by orthopedic surgeons in clinical/OR settings. Stems feature tapered geometry for press-fit fixation within femoral canal; designed to restore hip joint function and mobility. Modification from predicate includes expanded sizing range/increments and updated heat treatment for new sizes. Device provides structural support for prosthetic hip joint; benefits patients by alleviating pain and restoring joint function associated with degenerative hip conditions or fractures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, specifically engineering evaluations of geometric anatomical fit and fatigue strength testing.

Technological Characteristics

Materials: Titanium alloy, commercially pure titanium plasma spray. Design: Tapered 12/14 femoral stem geometry with standard/extended offsets. Fixation: Press-fit (option for cement use if non-HA coated). Sterilization: Gamma radiation (SAL 10^-6).

Indications for Use

Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip problems, 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 previous 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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## Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

NOV. - 8 2010.

Sponsor:

Exactech® Inc. 2320 N.W. 66th Court Gainesville, FL 32653

Phone: [phone] Fax: [phone]

FDA Establishment Number 1038671

(102-487

Vladislava Zaitseva Contact: Regulatory Affairs Specialist

Date: October 12, 2010

## Trade or Proprietary or Model Name(s):

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

#### Common Name:

Press-Fit Femoral Stem component

#### Classification Name:

- Prosthesis, hip. semi-constrained, metal/ceramic/polymer, cemented or non-● porous, uncemented. (CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Class II, Product Code LZO)
- Prosthesis, hip, semi-constrained, metal/polymer, uncemented. (CFR 888.3360 . Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Class II, Product Code LWJ)
- Prosthesis, hip, semi-constrained, metal/polymer, cemented. (CFR 888.3350. Hip joint metal/polymer semi-constrained cemented prosthesis Class II, Product Code JDI)

#### Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name · Manufacturer

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

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102487

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# Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

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 Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.

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

The modified devices share the following similarities with predicate devices:

- The same indications for use
- The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
- The same materials (titanium alloy, commercially pure titanium plasma spray) .
- 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 100).

This submission proposed the following design changes:

- A change to the sizing range and increments between additional femoral stem . sizes
- A heat treatment change for the additional femoral stem sizes only .

### Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Tapered 12/14 Press-Fit Femoral Stems:

- An engineering evaluation to determine that the geometric features of the ♥ proposed device correspond to the anatomical features of the femur.
- An engineering evaluation to determine that the proposed device has fatigue . strength equivalent to other comparable legally marketed femoral stems.

The results demonstrate that the proposed device is a substantially equivalent to the predicate device.

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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 with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

NOV - 8 2010

Re: K102487

Trade/Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LWJ Dated: October 12, 2010 Received: October 15, 2010

Dear Ms. Zaitseva:

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, Or R 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. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not maching.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your davice (1 https 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Сваване вмет

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K102487

# Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - Indications for Use

510(k) Number:

NOV: -- 8} 2010 :

ﻴﺔ

# Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems

## INDICATIONS

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 and/or (Part 21 CFR 801 Subpart D)

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)

K102487 Barbara Buend

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K102487