METHA HIP SYSTEM

K112682 · Aesculap Implant Systems, LLC · LZO · Mar 19, 2012 · Orthopedic

Device Facts

• Record ID: K112682
• Device Name: METHA HIP SYSTEM
• Applicant: Aesculap Implant Systems, LLC
• Product Code: LZO · Orthopedic
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 joint. 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, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise and nonunion of previous fractures of the femur. - patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis - patients with acute femoral neck fractures . - patients suffering from disability due to previous fusion .

Device Story

Short-stem hip prosthesis; single-piece or modular stem design; titanium alloy construction; proximal plasma-sprayed calcium phosphate coating for cementless press-fit fixation. Used by orthopedic surgeons in clinical settings for total hip replacement. Device replaces diseased or damaged hip joint to restore function and reduce pain. Clinical benefit derived from mechanical stabilization of femoral component within femur. Performance validated via fatigue testing per ISO 7206-4 and ASTM F2068-03.

Clinical Evidence

Bench testing only. Fatigue testing performed per ISO 7206-4 and ASTM F2068-03 to support substantial equivalence.

Technological Characteristics

Short stem design; titanium alloy; proximal plasma-sprayed calcium phosphate coating; cementless press-fit fixation; modular or single-piece options. Fatigue testing per ISO 7206-4 and ASTM F2068-03.

Indications for Use

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

• Metha Hip Systems (K080584 & K071916)
• MAYO Conservative Hip Prosthesis (K030733 & K061461)
• Profemur Hip System Modular Necks (K091423)

Submission Summary (Full Text)

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K 112 682

MAR 1 9 2012

Page 1 of 2

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

## Metha Hip System

February 29, 2012

COMPANY:

Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

CONTACT:

Kathv A. Racosky 610-984-9291 (phone) 610-791-6882 (fax)

Metha TRADE NAME:

Metha Hip System COMMON NAME:

CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis. Hip. Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented

888.3360, 888.3353, 888.3353 REGULATION NUMBER:

LWJ, MEH, LZO PRODUCT CODE:

### SUBSTANTIAL EQUIVALENCE

SUBSTANTIAL EGON ALLING
Aesculap Implant Systems, LLC believes that the Metha Hip Systems are substantially equivalent to:

- Metha Hip Systems (K080584 & K071916) .
- MAYO Conservative Hip Prosthesis (K030733 & K061461) .
- Profemur Hip System Modular Necks (K091423) .

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### DEVICE DESCRIPTION

The Metha Hip Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.

#### INDICATIONS FOR USE

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

The device is intended for:

- skeletally mature individuals undergoing primary surgery for total hip replacement i .
- Skeletally mature individuals and disability due to rheumatoid arthritis, . patterits suitening from severe hip pain and city and disorders, avascular USteoathinis, "traumatio" antimal" poryious fractures of the femur.
- heciosis of the congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- patients with acute femoral neck fractures .

# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

As is established in this submission, the Aesculap Implant Systems Melna Hip Systems As is established in this Submission, the Acceanap stem or a modular stem or a modular stem on the subjection are a short stem design with cither a cingle process cleared by FDA. The subject that are substantially equivalent to other productions the same technological device is shown to be substantially equivalism in design, intended use, onaterial composition, function and range of sizes.

### PERFORMANCE DATA

As recommended by the FDA Guidance for Industry and FDA Staff - Non-clinical As recommended by the PDA Guldance for Industry and to recomments that the Metha Information for Femoral Stem Prosmose that perceive devices. The following testing was performed to support substantial equivalence: -

- Fatigue testing per ISO 7206-4 and ASTM F2068-03 .
Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure embracing or protecting something.

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

MAR 1 9 2012

Aesculap Implant Systems, LLC. % Ms. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K112682

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, MEH, LWJ Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Rocosky:

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 (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. 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.

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.

sincerely yours,

For

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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### Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

K112.682

510(k) Number:_

# Device Name: Metha Hip System

#### Indications for Use:

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

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, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise 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 .

| Prescription Use | X | and/or Over-the-Counter 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 Surgical, Orthopedic,
and Restorative Devices510(k) Number K112682

002