(187 days)
K/DEN, Omnifit Hip System (Osteonics), PFC Cemented Total Hip System (Johnson & Johnson), Link SPII Hip System (Link), Exactech Cemented Total Hip System (Exactech)
Not Found
No
The summary describes a traditional mechanical hip replacement system with no mention of AI or ML in its design, function, or intended use.
Yes
The device is intended to treat a diseased or injured body part (severely disabled hip joints), which aligns with the definition of a therapeutic device.
No
This device is a total hip replacement system, indicated for the treatment of severely disabled hip joints. It functions to provide pain relief and improved function, not to diagnose a condition.
No
The device description clearly outlines physical components made of CoCrMo alloy and UHMWPE, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The ESKA Modular Hip System Cemented is a surgical implant used to replace a damaged hip joint within the body. Its function is mechanical, providing structural support and allowing for movement.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic procedures performed outside the body.
This device is a Class III medical device (based on the nature of a total hip replacement) and is used for surgical intervention, not in vitro diagnosis.
N/A
Intended Use / 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-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.
Product codes
JDI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omnifit Hip System (Osteonics), PFC Cemented Total Hip System (Johnson & Johnson), Link SPII Hip System (Link), Exactech Cemented Total Hip System (Exactech)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 22 2003
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
- 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.
-
- 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.
1
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