ESKA MODULAR HIP SYSTEM CEMENTED

K030867 · Eska Implants GmbH · JDI · Sep 22, 2003 · Orthopedic

Device Facts

• Record ID: K030867
• Device Name: ESKA MODULAR HIP SYSTEM CEMENTED
• Applicant: Eska Implants GmbH
• Product Code: JDI · Orthopedic
• Decision Date: Sep 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESKA Modular Hip System Cemented is indicated for cemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

Device Story

Total hip replacement system for severely disabled hip joints. Components include femoral stems, modular femoral heads, and acetabular components. Stems feature anatomical design, anteverted necks, grit-blasted surfaces, and 12/14 Morse type taper trunnion. Acetabular components are hemispherical all-polyethylene with cement retention grooves and titanium radiographic marker wire. Used by orthopedic surgeons in clinical settings to replace arthritic or traumatized hip joints. Provides pain relief and improved joint function.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional characteristics.

Technological Characteristics

Materials: CoCrMo alloy and UHMWPE per ASTM and ISO standards. Design: Modular femoral stems (collared/collarless), femoral heads (26-32mm), and hemispherical all-polyethylene acetabular components. Features: 12/14 Morse type taper trunnion, grit-blasted stem surface, cement retention grooves, and titanium radiographic marker wire. Cemented fixation.

Indications for Use

Indicated for patients with severely disabled hip joints due to painful osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, or requiring revision of previous hip surgeries. For cemented use.

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

• Omnifit Hip System (Osteonics)
• PFC Cemented Total Hip System (Johnson & Johnson)
• Link SPII Hip System (Link)
• Exactech Cemented Total Hip System (Exactech)

Submission Summary (Full Text)

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SEP 22 2003

K030867

Summary of Safety and Effectiveness for the

## ESKA Modular Hip System Cemented

Page lofl

This safety and effectiveness summary for the ESKA Modular Hip System Cemented is provided as required per Section 513(i(3) of the Frood, Drug and Cosmetic Act.

| 1. Submitter : | Contact Person : |
|--------------------------|-------------------------------------|
| ESKA Implants GmbH & Co. | Thomas P. Monkus, RAC |
| Grapengießerstraße 34 | ESKA America Corporation |
| D-23556 Lübeck | 101 Riverfront Boulevard, Suite 600 |
| ( 0451 ) 89000-0 | Bradenton, FL 34205 |
| | Telephone: ( 941 ) 744-5400 |

Date Prepared: May 20, 2003

2. Trade Name: ESKA Modular Hip System Cemented Common Name: Total Hip System Classification Name: Hip joint metal /polymer semi-constrained cemented prosthesis ( 888.3350 )

## 3. Predicate or legally marketed devices which are substantially equivalent :

- . Omnifit Hip System ( Osteonics )
- . PFC Cemented Total Hip System ( Johnson & Johnson )
- Link SPII Hip System ( Link ) ●
- Exactech Cemented Total Hip System ( Exactech ) ●

## 4. Description of the device :

The ESKA Modular Hip System Cemented is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The modular femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. They are available in varying primary and revision lengths. There are collared and collarless options. Standard and lateralized geometries are offered. The stems feature a grit-blasted surface along their entire length and a 12/14 Morse type taper trunnion.

The modular femoral heads are available in various diameters from 26mm to 32mm, and in varying neck lengths.

The acetabular components are hemispherical all-polyethylene designs in a range of inner and outer diameters, with various offset options. The outer diameters incorporate radial and circumferential cement retention grooves and a titanium radiographic marker wire.

Materials: The devices are manufactured from CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

## 5. Intended Use:

The ESKA Modular Hip System Cemented is indicated for cemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices : There are no significant differences between the ESKA Modular Hip System Cemented and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of three birds in flight, arranged in a diagonal line from the upper right to the lower left. The birds are simple, with curved lines representing their bodies and wings. Encircling the birds is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

SEP 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ESKA Implants GMbH & Co. c/o Mr. Thomas Monkus, RAC Director, Regulatory Affairs & Business Development ESKA America Corporation 101 Riverfront Boulevard. Suite 600 Bradenton, FL 34205

Re: K030867

Trade/Device Name: ESKA Modular Hip System Cemented Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: August 20, 2003 Received: August 21, 2003

Dear Mr. Monkus:

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 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.

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Page 2 - Mr. Thomas Monkus, RAC

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours.

sincerely yours.

Mark M. Mellem

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number ( if known ) :

Device Name : ESKA Modular Hip System Cemented

Indications For Use :

The ESKA Modular Hip System Cemented is indicated for cemented use in the treatment of severely disabled hip joints resulting from painful osteo-, theumatoid and post-traumatic arthritis. and the late stages of avascular necrosis, and for revision of previous hip surgeries.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation ( ODE )

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Prescription use ( PER 21 CFR 801.109) OR

Over-the-counter use

( optional format 1-2-96 )

Mark A. Meltzer

Restorative

510(k) Number K 03 0867