ENDO HEAD

K111145 · Medacta International · LZY · Aug 16, 2011 · Orthopedic

Device Facts

• Record ID: K111145
• Device Name: ENDO HEAD
• Applicant: Medacta International
• Product Code: LZY · Orthopedic
• Decision Date: Aug 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: · Femoral neck and trochanteric fractures of the proximal femur; · Osteonecrosis of the femoral head; · Revision procedures where other devices or treatments for these indications have failed.

Device Story

Medacta Endo Head is a unipolar prosthetic femoral head; monobloc design; manufactured from Cobalt Chromium Molybdenum (CoCrMo). Device functions as a hemiarthroplasty component, articulating directly within the patient's acetabulum. Designed for assembly with Medacta hip stems via 12/14 Morse taper. Available in three sizes (S, M, L) with outer diameters ranging from 40 to 56 mm. Used by orthopedic surgeons in clinical/surgical settings for hip reconstruction. Provides structural replacement for femoral head; restores joint function; benefits patients by addressing fractures or necrosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and mechanical comparison to legally marketed predicate devices.

Technological Characteristics

Material: Cobalt Chromium Molybdenum (CoCrMo) per ISO 5832-12. Form factor: Monobloc unipolar femoral head. Connection: 12/14 Morse taper for assembly with Medacta stems. Sizes: S, M, L; 40-56 mm diameter range. Mechanical articulation with acetabulum.

Indications for Use

Indicated for patients requiring primary or revision hemiarthroplasty of the hip due to femoral neck/trochanteric fractures of the proximal femur, osteonecrosis of the femoral head, or failure of previous treatments.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Smith & Nephew Unipolar System (K896580)
• Smith & Nephew Modular Femoral (Hemi) Heads (K062408)
• Medacta CoCrMo Femoral Ball Heads, 28 and 32mm (K072857)
• Medacta CoCrMo Femoral Ball Heads, 22 and 36mm (K080885)
• Medacta CoCrMo Femoral Ball Heads, 40mm (K103721)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the handwritten text "K111145" above the logo for Medacta International. The Medacta logo features a stylized mountain range with the company name to the right. Below the logo, the word "International" is printed in a smaller font, and a plus sign is located to the right of the word.

AUG 1 6 2011

# 510(k) Summary

Manufacturer: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] FAX [phone]

Contact Person: Adam Gross Director of Regulatory and Quality Medacta USA Office: 805-437-7085 x26 Cell: 805-910-6511 Fax: [phone] [e-mail]

April 19th, 2011 Date Prepared:

### DEVICE INFORMATION

Trade/Proprietary Name: Endo Head Common Name: Unipolar Head Classification Name: prosthesis, hip, hemi-, femoral, metal ball

> 21 CFR 888.3360 Class II Device Product Codes: LZY

Predicate Devices:

K896580 - Smith & Nephew Unipolar System K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072857 - Medacta CoCrMo Femoral Ball Heads, 28 and 32mm

- K080885 Medacta CoCrMo Femoral Ball Heads, 22 and 36mm K103721 - Medacta CoCrMo Femoral Ball Heads, 40mm
Endo Head 510(k)

Section 5 - Page Z of A

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K川 45

### Product Description

The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.

# Indications for Use

The Medacta Endo Head is intended for use in combination with Medacta Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

· Femoral neck and trochanteric fractures of the proximal femur;

- · Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.

### Comparison to Predicate Devices

The Endo Head has the same intended use, material, neck lengths, and external diameter size range as the previously cleared Unipolar System manufactured by Smith and Nephew (K896580). The Endo Head's material, sterilization, biocompatibility, and coupling with the Medacta stems is substantially equivalent to the Medacta CoCr Femoral Heads cleared under K072857, K080885, and K103721.

#### Conclusion:

Based on the above information, the Endo Head can be considered as substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health. The logo features a stylized human figure with three lines representing the head, torso, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & H.", which is arranged in a circular fashion.

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

Medacta International % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4275 Calle Quetzal. Unit B Camarillo, California 91302

AUG 1 6 2011

Re: K111145

Trade/Device Name: Endo Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LZY Dated: July 28, 2011 Received: July 29, 2011

Dear Mr. Gross:

We have reviewed vour 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 (21

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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/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 yours,

Mark N. Mollenhour

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 Statement

# 510(k) Number (if known): K111145

Device Name: Endo Head

Indications For Use:

The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

· Femoral neck and trochanteric fractures of the proximal femur;

· Osteonecrosis of the femoral head;

· Revision procedures where other devices or treatments for these indications have failed.

Prescription Use × (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

for m. Mellers on

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

510(k) Number K111145

Section 4 - Page 2 of 2

Endo Head 510(k) July 28, 2011