Exactech Alteon Monobloc Revision Stem

K150066 · Exactech, Inc. · LZO · Jul 20, 2015 · Orthopedic

Device Facts

• Record ID: K150066
• Device Name: Exactech Alteon Monobloc Revision Stem
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 20, 2015
• Decision: SESE
• Submission Type: Traditional
• 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 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. - Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Story

Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis for total or hemi hip arthroplasty; implanted in the femur. Device features 12/14 trunnion; manufactured from titanium alloy; available in multiple lengths, offsets, and diameters to match patient anatomy. Used by orthopedic surgeons in clinical settings to replace diseased or damaged hip joints. Provides structural support and restores joint function; benefits patients by alleviating pain and improving mobility. Surgeon selects appropriate size based on patient anatomy; device is implanted via press-fit technique.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing including fatigue testing, range of motion analysis, cadaveric implantation with surgeon assessment, and biocompatibility assessment.

Technological Characteristics

Distally tapered, press-fit femoral stem; titanium alloy construction; 12/14 trunnion; multiple lengths, offsets, and diameters. Mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature individuals requiring primary or revision hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, proximal femoral fractures, ankylosing spondylitis, congenital hip dysplasia, or to restore 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

• Wagner SL Revision Stem (K043356)

Submission Summary (Full Text)

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

July 20, 2015

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653

Re: K150066 Trade/Device Name: Exactech Alteon Monobloc Revision Stem 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 Dated: May 28, 2015 Received: May 29, 2015

Dear Mr. Patrick Hughes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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(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 forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

## 510(k) Number (if known) K150066

Device Name Exactech Alteon Monobloc Revision Stem

#### Indications for Use (Describe)

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.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Exactech® Alteon™ Monobloc Revision Stem Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech, Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653 |
|----------|-----------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | FDA Establishment Number 1038671 |
| Contact: | Patrick Hughes<br>Senior Regulatory Affairs Specialist |
| Date: | January 12, 2015 |

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

Exactech® Alteon™ Monobloc Revision Stem

#### Common Name:

Total Hip Arthroplasty – Femoral Components

# 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)

# Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---------------|---------------------------------|--------------|
| K043356 | Wagner SL Revision Stem | Zimmer |

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# Exactech® Alteon™ Monobloc Revision Stem Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

# 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.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.

# Device Description:

The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Alteon Monobloc Revision Stem implants are made from titanium alloy and offer multiple stem lengths, offsets, and diameters to accommodate an array of patient anatomies.

# Testing:

This submission includes results for the following non-clinical testing:

- Fatigue testing ●
- Range of motion analysis
- Cadaveric implantation and surgeon assessment ●
- Biocompatibility assessment ●

# Substantial Equivalence Conclusion:

Results of engineering studies and comparison of key features included in this submission demonstrate the proposed Alteon Monobloc Revision Stem devices are substantially equivalent to cleared predicate Zimmer Wagner SL Revision Stem devices.