INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL

K122798 · Exactech, Inc. · LPH · Oct 11, 2012 · Orthopedic

Device Facts

• Record ID: K122798
• Device Name: INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
• Applicant: Exactech, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• 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. - Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Story

The Exactech InteGrip Acetabular Shells are orthopedic implants for total hip arthroplasty. These titanium alloy shells are designed for press-fit fixation in the acetabulum. The device modifications include the addition of outer diameter cut-outs for optional augment attachments and a revision version featuring 9 or 12 holes for adjunctive screw fixation. Used by orthopedic surgeons in clinical settings, the device provides a stable prosthetic socket for the hip joint. The shell serves as a mechanical component to restore joint function and mobility in patients with degenerative hip conditions. The design maintains compatibility with existing Exactech hip system components.

Clinical Evidence

Bench testing only. Engineering analyses were performed to evaluate the structural integrity of the shell modifications, specifically assessing stress distribution related to the addition of screw holes and cut-outs for augment attachments.

Technological Characteristics

Titanium alloy acetabular shells; press-fit fixation; features include outer diameter cut-outs for augments and 9 or 12 screw holes for revision applications; gamma radiation sterilization (SAL 10^-6); 10-year shelf life.

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, and revision of failed reconstructions with sufficient bone stock.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Novation® Crown Cup™ with InteGrip™ (K102975)

Submission Summary (Full Text)

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# Exactech® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness

OCT 1 1 2012

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

> Phone: [phone] [phone] Fax:

FDA Establishment Number 1038671

Amy Taulbee Contact: Regulatory Affairs Specialist

Date: September 11, 2012

# Trade of Proprietary or Model Name(s): Exactech® InteGrip™ Acetabular Shell
Exactech® InteGrip™ Revision Acetabular Shell

Common Name: Total Hip Arthroplasty - Acetabular Components

#### Classification Name:

Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Class II, Product Code LPH)

Information on devices to which substantial equivalence is claimed:

Trade of Proprietary Model Name Manufacturer 510(k) Number Novation® Crown Cup™ with InteGrip™ K102975 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.

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# Exactech® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness

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

The proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells are modifications to the Novation Crown Cup with InteGrip acetabular shell devices cleared through premarket notification #K102975.

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

The modified devices share the following similarities with the predicate devices:

- . Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical i locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (10 years) .
- Packaging and sterilization materials and processes (gamma radiation . sterilization to a sterility assurance level of 10th).

This submission proposes the following design change:

- Addition of cut-outs on the outer diameter to accommodate optional augment . attachments.
- . Addition of InteGrip Revision Acetabular Shells with 9 or 12 holes, depending on shell size, for additional adjunctive screw fixation.

#### Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells to the predicate Novation Crown Cup with InteGrip acetabular shells:

- Engineering analyses to evaluate stress on shell with screw holes and cut-outs. .
- Evaluation to assess InteGrip Revision Acetabular Shell screw hole number and ● placement.
- Evaluation to assess cut-out placement on the acetabular shells. .

The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

OCT
11
2012

Exactech. Inc. % Ms. Amy Taulbee Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K122798

K122796
Trade/Device Name: Exactech InteGrip Acetabular Shell, Exactech InteGrip Revision Acetabular Shell

Regulation Number: 21 CFR 888.3358

Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis

Regulatory Class: II Product Codes: LPH, LZO, KWZ, JDI Dated: September 11, 2012 Received: September 12, 2012

Dear Ms. Taulbee:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications forcenced in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that hat to been 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, cherely mains 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 adulteration. Trease now, 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 may of subject to additions, 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 I lease be devilsed that I Dr i resumes of your device complies with other requirements of the Act that I Dri has made a actorized administered by other Federal agencies. You must or any I odolar battler and a media ments, including, but not limited to: registration and listing (21

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Page 2 - Ms. Amy Taulbee

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

-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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# Exactech® InteGrip™ Acetabular Shells Special 510(k) - Indications for Use

510(k) Number: K122798

Device Name: Exactech® InteGrip™ Acetabular Shells

### 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. .
- 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)

Peter G. Oblein for Anton Dmitriev

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

510(k) Number K122798