MODIFICATION TO: METHA HIP SYSTEM

K083495 · Aesculap Implant Systems, Inc. · LZO · Jan 15, 2009 · Orthopedic

Device Facts

• Record ID: K083495
• Device Name: MODIFICATION TO: METHA HIP SYSTEM
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip ioint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement . patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures

Device Story

Metha® Hip System is a line extension of existing hip prostheses; includes ceramic femoral heads (BIOLOX® forte/delta) and cementless femoral stems. Femoral heads available in 28, 32, 36 mm diameters; stems feature Plasmapore® u-Cap coating on proximal two-thirds. Used by orthopedic surgeons in clinical settings for total hip replacement. Device replaces damaged hip joint to restore function and alleviate pain. Substantial equivalence established via comparison to existing Metha® components and BIOLOX® ceramic heads.

Clinical Evidence

Bench testing only. Testing conducted per FDA guidance for orthopedic devices, including evaluations for metallic plasma-sprayed coatings, non-articulating modular components, acetabular cup prostheses, femoral stem prostheses, and ceramic ball hip systems.

Technological Characteristics

Materials: Alumina (Al2O3) per ISO 6474 (BIOLOX® forte), alumina matrix composite (BIOLOX® delta), and Titanium per ISO 5832 (femoral stem). Features: Plasmapore® u-Cap coating on proximal stem. Modular design with varying head diameters (28, 32, 36 mm) and neck lengths. Uncemented, press-fit fixation.

Indications for Use

Indicated for skeletally mature patients undergoing primary total hip replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, femoral nonunion, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, previous fusion, or acute femoral neck fractures.

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

• Metha® Hip System (K071916)
• Metha® Hip System (K080584)
• BIOLOX delta Ceramic Femoral Head (K082991)

Submission Summary (Full Text)

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SPECIAL 510(k) Premarket Notification

Page 1 of 2

#### 510(k) SUMMARY (as required by 21 CFR 807.92) 8.

## Metha® Hip System

JAN 1 5 2009

Metha® Hip System Line Extension

November 25, 2008

COMPANY:

Aesculap implant Systems, Inc. 3773 Corporate Parkway Center Vallev. PA 18034 Establishment Registration Number: 3005673311

CONTACT:

Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathv [e-mail] (email)

| TRADE NAME: | |
|----------------------|--|
| COMMON NAME: | |
| CLASSIFICATION NAME: | |

Metha®

Metha® Hip System

E: Hip ioint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis Prosthesis. Hip. Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented

REGULATION NUMBER: 888,3353,888,3360,888,3353,888,3390

PRODUCT CODE: LZO, LWJ, MEH, KWY

#### SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that the Metha® Hip System additions are substantially equivalent to the existing components of the Metha® Hip Systems (K071916 and K080584) and Aesculap Implant Systems. Inc. BIOLOX delta Ceramic Femoral Head (K082991).

#### DEVICE DESCRIPTION

The Metha® BIOLOX® forte and delta ceramic femoral head are available in head diameters of 28, 32, and 36 mm with a range of neck lengths. The BIOLOX® forte ceramic heads are manufactured from ceramic (Al2O3) and conforms to ISO 6474. The BIOLOX® delta ceramic heads are manufactured from an alumina matrix composite. The Metha® cementless femoral stem will be offered in an additional size. The Metha® femoral stem has a Plasmapore® u-Cap coating on the proximal two thirds of the stem and is manufactured from Ti which conforms to ISO 5832.

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Page 2 of 2

# INDICATIONS FOR USE

# The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip ioint.

The device is intended for:

- skeletally mature individuals undergoing primary surgery for total hip replacement .
- . patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- . patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
- 0 patients suffering from disability due to previous fusion
- t patients with acute femoral neck fractures

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Implant Systems Metha® Hip System additional components are offered in similar shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems devices are the same as that used to manufacture the predicate devices.

### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. addition, testing per the;

- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Spraved Coatings on 0 Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
- 0 "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components".
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", .
- "Points to Consider for Femoral Stem Prostheses",
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weight Polethevlene (UHMWPE) Used in � Orthopedic Devices" was completed where applicable.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, Pennsylvania 18034

#### JAN 1 5 2009

Re: K083495

Trade/Device Name: Metha® Hip System 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, LWJ, MEH, KWY Dated: January 2, 2009 Received: January 5, 2009

Dear Ms. Racosky:

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.

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

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Page 2 – Ms. Kathy A. Racosky

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark N. Millerson

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

Enclosure

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Metha® Hip System

Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

510(k) Number:

Metha® Hip System Device Name:

Indications for Use:

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip ioint.

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement �

- patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoanthritis, traumatic arthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral � epiphysis
- patients suffering from disability due to previous fusion 0

patients with acute femoral neck fractures

× and/or Over-the-Counter Use Prescription Use

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
12013498