EXETER HIP STEM

K110290 · Howmedica Osteonics Corp. · JDI · Sep 27, 2011 · Orthopedic

Device Facts

• Record ID: K110290
• Device Name: EXETER HIP STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only. The Exeter® Hip is indicated for: - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - rheumatoid arthritis; - correction of functional deformity; - revision procedures where other treatments or devices have failed; and - treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Story

Exeter® Hip Stem is a femoral component for total hip arthroplasty; intended for cemented fixation. Device functions as a structural replacement for the proximal femur. This 510(k) expands compatibility to include Howmedica Osteonics' V40™ cobalt chrome alloy femoral heads and Universal Taper Biolox® Delta Ceramic heads (via titanium alloy adaptor sleeve). Used in clinical settings by orthopedic surgeons. Output is a mechanical interface for hip joint reconstruction; aids in restoring joint function and mobility. Benefits include treatment of degenerative joint disease and complex fractures.

Clinical Evidence

No clinical data provided. Equivalence established via bench testing, including axial pull-off, axial fatigue, post-fatigue ultimate compression (ISO 7206-10, ISO 7206-6), and galvanic corrosion/fretting evaluation (ASTM G 71-81).

Technological Characteristics

Femoral stem manufactured from stainless steel. Compatibility with cobalt chrome alloy and Biolox® delta ceramic femoral heads; titanium alloy adaptor sleeve used for ceramic heads. Mechanical fixation via cement. Testing standards: ISO 7206-10 (axial pull-off/compression), ISO 7206-6 (ultimate compression), ASTM G 71-81 (galvanic corrosion).

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments/devices, or proximal femur fractures (nonunion, femoral neck, trochanteric) with head involvement. Intended for cemented use only.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Exeter V40 Hip System (K011623)

Reference Devices

• Meridian TMZF Femoral Hip Stem (K972228)
• V40™ taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757)
• Universal Taper Biolox® Delta Ceramic heads (K070885)

Submission Summary (Full Text)

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K110290

# SEP 2 7 2011

| Sponsor | Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Valerie Giambanco<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Exeter® Hip Stem |
| Common Name: | Artificial Hip Replacement Components - Femoral Stem |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer semi-constrained<br>cemented prosthesis |
| Regulatory Class: | Class II |
| Product Codes: | JDI |
| Predicate Device: | Exeter V40 Hip System |
| Date Prepared: | September 20, 2011 |

# 510(k) Summary of Safety and Effectiveness

### Description:

The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.

#### Intended Use:

The Exeter® hip is intended for use in total hip arthroplasty. They are intended for cemented use only. The Exeter® hip is provided sterile for single-use.

The Exeter® Femoral Stems are currently cleared for use with femoral heads manufactured from Zirconia, alumina ceramic, Biolox® delta ceramic, and stainless steel. The purpose of this 510(k) is that the Exeter® stems will now be marketed as compatible with Howmedica Osteonics' V40™ cobalt chrome alloy femoral heads and Universal Taper Biolox® Delta Ceramic heads when using a titanium alloy sleeve. Thus, Exeter® stem size range cleared in K011623 will be compatible with V40™ Taper femoral heads manufactured frome alloy, alumina ceramic, Biolox® delta ceramic (Zirconia toughened), and stainless steel and a Universal Taper femoral heads manufactured from Biolox® delta ceramic only when using a titanium alloy adaptor sleeve.

#### Indications:

The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only .

The Exeter® Hip is indicated for:

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- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- rheumatoid arthritis; .
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

# Substantial Equivalence:

The Exeter® hip stem continues to be manufactured from the same material via the same process and same design as the Exeter® hips that were cleared in K011623. The Exeter® Hip Stems are substantially equivalent to other commercially available hip arthroplasty systems in regards to indications for use design, materials, and operational principles. The femoral head compatibility of the Exeter Hip Stem is substantially equivalent to Meridian TMZF Femoral Hip Stem that was cleared via K972228 . The following devices are examples of predicate systems currently cleared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V40™ taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885).

Summary of Technologies: The technological characteristics (material, design, sizes, and operational principles) of the Exeter® V40™ Hip Stem are similar or identical to the predicate devices.

# Summary of Non-Clinical Testing and Evaluation:

Testing has been performed to demonstrate equivalence of the subject device intended use compared to its predicate device intended use. Additional testing was conducted on the cobalt chrome alloy and Universal taper Biolox® delta ceramic femoral heads with the corresponding titanium alloy sleeves when used with Exeter® stainless steel femoral stems.

New testing to support this additional compatibility for the Exeter® Femoral Stem with cobalt chrome femoral heads includes an Axial Pull-off testing.

New testing to support this additional compatibility for the Exeter® Femoral Stem with the Universal taper Biolox® delta ceramic femoral heads with titanium sleeve includes Axial fatigue & post fatigue ultimate compression testing (according to ISO 7206-10), Axial pull-off testing (according to ISO 7206-10) and ultimate compression testing on both new and "damaged or used" femoral stem tapers (per ISO 7206-6).

For both the cobalt chrome alloy heads and titanium alloy sleeves when used with stainless steel Exeter Stems, testing for galvanic corrosion (according to ASTM G 71-81) was conducted and fretting was evaluated as compared to the predicate device.

### Clinical Testing

None provided as a basis for substantial equivalence

#### Conclusion

The Exeter® V40™ Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W 066-G609 Silver Spring, MD 20093-0002

Howmedica Osteonies Corp. % Ms. Valerie Giambanco 325 Corporate Drive Regulatory Affairs Specialist Mahwah, New Jersey 07430

SEP 2 7 2011

Re: K110290

Trade/Device Name: The Exeter® V40 hip stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: HDI Dated: August 16, 2011 Received: August 17, 2011

Dear Ms. Giambanco:

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 is 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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Page 2 - Ms. Valerie Giambanco

forth in the quality svstems (QS) regulation (2) 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.html 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/Safetv/ReportalProblem/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.

Ernst Keith

C, 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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# Indications for Use

510(k) Number (if known): k110290

Indications for Use:

The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.

The Exeter® Hip is indicated for:

- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis; ●
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Michael lulus for MXM

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

510(k) Number K110290