ESKA MODULAR HIP SYSTEM CEMENTED by ESKA IMPLANTS GMBH

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 Description

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.

AI/ML Overview

This submission describes a 510(k) premarket notification for the ESKA Modular Hip System Cemented. This type of submission does not typically involve a clinical study to establish acceptance criteria and device performance in the same way a PMA (Pre-Market Approval) or de novo submission would. Instead, the primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device that is already legally marketed.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, expert involvement, and ground truth establishment is not directly applicable in the context of this 510(k) summary.

Here's an explanation of why those categories are not present and what this document does provide:

Acceptance Criteria and Reported Device Performance:
- In a 510(k), the "acceptance criterion" is typically that the device is substantially equivalent to a predicate device. This means it performs as safely and effectively as a legally marketed device.
- The "reported device performance" is demonstrated through a comparison of technological characteristics to the predicate devices, showing no significant differences that would adversely affect its use. The summary states: "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."
Sample Size used for the test set and the data provenance, Number of experts used to establish the ground truth, Adjudication method, MRMC comparative effectiveness study, Standalone performance:
- These concepts relate to clinical studies involving human subjects or analyses of clinical data outcomes to validate a device's performance.
- A 510(k) such as this one for a hip prosthesis, especially one based on established materials and designs, primarily relies on non-clinical performance data (e.g., mechanical testing, materials testing, design specifications) to show substantial equivalence.
- There is no mention of a human-based test set, data provenance, experts, adjudication, or clinical comparative effectiveness study in this document. The basis for "equivalence" would come from engineering and material comparisons, often against established standards.
Type of ground truth used:
- Since there isn't a clinical performance study with human subjects validating outcomes, the concept of "ground truth" (like pathology, expert consensus, or outcomes data) as it pertains to clinical accuracy or efficacy isn't applicable here.
- The "truth" established for this 510(k) is that the device's design, materials, and intended use are similar enough to existing, legally marketed devices.
Sample size for the training set, How the ground truth for the training set was established:
- These terms are typically relevant for AI/ML device submissions where a model is trained on a dataset.
- This document is for a mechanical orthopedic implant, not an AI-powered device. Therefore, there is no "training set" in this context.

Summary of what the document does provide regarding equivalence and "performance":

Predicate Devices: The device is compared to the following legally marketed predicate devices:
- Omnifit Hip System (Osteonics)
- PFC Cemented Total Hip System (Johnson & Johnson)
- Link SPII Hip System (Link)
- Exactech Cemented Total Hip System (Exactech)
Comparison Basis: The document states that the ESKA Modular Hip System Cemented is "substantially equivalent to these other devices in design, function, material and intended use." It specifically highlights:
- Design: Anatomically designed femoral stems (left/right, anteverted necks, collared/collarless, standard/lateralized geometries), modular femoral heads (various diameters/neck lengths), hemispherical all-polyethylene acetabular components (various inner/outer diameters, offset options, cement retention grooves, radiographic marker wire).
- Materials: CoCrMo alloy and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM and ISO standards.
- Function: Provides pain relief and improved function to the hip, similar to predicate devices.
- Intended Use: Cemented use for treatment of severely disabled hip joints from painful osteo-, rheumatoid, post-traumatic arthritis, late stages of avascular necrosis, and revision surgeries.

In conclusion, this 510(k) submission establishes the device's marketability by demonstrating its substantial equivalence to existing devices through a detailed comparison of its design, materials, and intended use, rather than through a clinical study with detailed performance metrics and expert-established ground truth.

Summary

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SEP 22 2003

K030867

Summary of Safety and Effectiveness for the

ESKA Modular Hip System Cemented

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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

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

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:

1. 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1

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 )

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

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.