EXACTECH NOVATION CROWN CUP AND LINERS

K070479 · Exactech, Inc. · LZO · Mar 15, 2007 · Orthopedic

Device Facts

• Record ID: K070479
• Device Name: EXACTECH NOVATION CROWN CUP AND LINERS
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Mar 15, 2007
• 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 Crown Cup and Liners are acetabular components for hip arthroplasty; modifications of previously cleared AcuMatch A-Series predicates. Shells manufactured from titanium alloy with plasma coating and optional hydroxyapatite (HA) coating. Design options include No-Hole and Cluster Hole configurations; sphere and taper inner diameter geometry. Used by orthopedic surgeons in clinical settings for hip replacement procedures. Device provides a prosthetic acetabular surface to restore hip joint function and mobility. Performance verified through engineering evaluations to ensure adequacy for in vivo use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Acetabular shell manufactured from titanium (Ti) alloy with plasma coating and optional hydroxyapatite (HA) coating. Features No-Hole and Cluster Hole design options with sphere and taper inner diameter geometry. Non-software device.

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 A-Series Porous Coated Cups and Liners (K993082)
• AcuMatch A-Series Corundum Cups (K000242)
• AcuMatch A-Series GXL Liners (K051556)

Submission Summary (Full Text)

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Exactech®

K070479 Rge 3 2320 NW 66TH COURT

GAINESVILLE, FL 32653

352-377-1140 FAX [phone]

# Exactech® Novation Crown Cup™ and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

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

| <b>Phone:</b> | (352) - 377 - 1140 | MAR 1 5 2007 |
|---------------|--------------------|--------------|
| <b>Fax:</b> | (352) - 378 - 2617 | |

FDA Establishment Number 1038671

Contact: Maritza Elias Regulatory Representative

Date: February 12, 2007

....

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2320 NW 66TH COURT GAINESVILIE FL 32653

352-377-1141 FAX [phone]

Exactech® Novation Crown Cup™ and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

Trade or proprietary or model name(s):

Novation Crown Cup and Liners

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

| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|----------|-------------------------------------------------|----------------|
| Number | | |
| #K993082 | AcuMatch A-Series Porous Coated Cups and Liners | Exactech, Inc. |
| #K000242 | AcuMatch A-Series Corundum Cups | Exactech, Inc. |
| #K051556 | AcuMatch A-Series GXL Liners | 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 Crown CupsTM and Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:

## NOVATION CROWN CUP AND LINERS

- No-Hole and Cluster Hole design options
- Shells manufactured from titanium (Ti) alloy with plasma coating and an additional hydroxylapitite (HA) coating option
- Sphere and taper inner diameter geometry .

Section 4 Page 2 of 3

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# Exactech® Novation Crown Cup™ and Liners

352-377-1140 FAX [phone]

# Substantial Equivalency Conclusion:

Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.

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

Section 4 Page 3 of 3

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 5 2007

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

Re: K070479

> Trade/Device Name: Novation Crown Cups and Liners 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, MEH, LPH Dated: February 12, 2007 Received: February 20, 2007

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.

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# Page 2 -- Ms. Maritza Elias

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. 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 BruchuD
tor

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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### Exactech® Novation Crown Cup™ and Liners Special 510(k) - Indications for Use

510(k) Number (if known):

Novation Crown Cup™ and Liners 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 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 Device Evaluation (ODE) Concurrence of CDRH, Office of (Division Sign-Off) Section 3 Division of General, Restorative, Page 1 of 1 and Neurological Devices 510(k) Num