(270 days)
Not Found
Not Found
No
The summary describes a mechanical implant for hip replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as treating severely disabled hip joints, providing pain relief and improved function, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is an acetabular component for a total hip replacement system, indicated for treating severely disabled hip joints. Its function is to provide pain relief and improved function, not to diagnose a condition.
No
The device description clearly states it is a system of physical components (acetabular shells, femoral heads, acetabular liners) made from materials like CoCrMo alloy and UHMWPE, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of severely disabled hip joints and revision of previous hip surgeries. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical implant (acetabular components, femoral stems, heads, and liners) made of materials like CoCrMo alloy and UHMWPE. These are components for surgical implantation, not for analyzing biological samples.
- Function: The stated function is to provide pain relief and improved function to the hip, which is a clinical outcome, not a diagnostic result.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis or monitoring of a disease or condition in vitro.
In summary, the ESKA Modular Total Hip System Acetabular Components are a surgical implant used for the treatment of hip conditions, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ESKA Modular Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
Product codes
LPH
Device Description
The ESKA Modular Hip System Acetabular Components are modular components used in conjunction with the company's femoral stems, for the replacement of severely disabled hip joints. The system consists of porous acetabular shells, modular femoral heads, and modular acetabular liners. The acctabular components are porous coated hemispherical shells with modular UHMWPE inserts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
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Summary of Safety and Effectiveness
for
ESKA Modular Hip System Acetabular Components
This safety and effectiveness summary for the ESKA Modular Hip System Acetabular Components is provided as required per Scction 513(i)(3) of the Food, Drug and Cosmetic Act.
MAR 0 4 2003
| 1. Submitter : | Contact Person : |
|---|---|
| ESKA Implants GmbH & Co. | Thomas P. Monkus |
| Grapengießerstraße 34 | ESKA America Corporation |
| D-23556 Lübeck, Germany | 101 Riverfront Blvd., Suite 600 |
| (49) 451 89000-0 | Bradenton, FL 34205 |
| Telephone: (941) 744-5400 |
Date Prepared: February 25, 2003
- Tradename : ESKA Modular Hip System Acetabular Components Common Name : Total Hip System Classification Name : Hip joint metal /polymer/ metal semi-constrained porous uncemented prosthesis ( 888.3358 )
3. Predicate or legally marketed devices which are substantially equivalent :
- . PFC Total Hip System ( Johnson & Johnson )
- ESKA Modular Hip System ( ESKA America ) ●
- Vitalock Acetabular System ( Howmedica Stryker Osteonics ) ●
- PCA Cluster Acetabular System ( Howmedica Stryker Osteonics ) ●
4. Description of the device :
The ESKA Modular Hip System Acetabular Components are modular components used in conjunction with the company's femoral stems, for the replacement of severely disabled hip joints. The system consists of porous acetabular shells, modular femoral heads, and modular acetabular liners. The acctabular components are porous coated hemispherical shells with modular UHMWPE inserts.
Materials: The devices are manufactured from CoCrMo alloy, 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 Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic arthritis, and the late stages of avascular necrosis, and for 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 Acetabular Components 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 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 an eagle with its wings spread, facing to the right. The eagle is depicted with three parallel lines forming its body and wings.
MAR 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ESKA Implants GmbH & Co. c/o Mr. Thomas P. Monkus, RAC Director, Regulatory Affairs and Business Development ESKA America Corporation 101 Riverfront Boulevard, Suite 600 Bradenton, Florida 34205
Re: K021878
Trade/Device Name: ESKA Modular Hip System Acetabular Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 2, 2002 Received: December 4, 2002
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
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Page 2 - Mr. Thomas P. Monkus, RAC
forth in the quality systems (OS) 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 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 vours.
R. Mark A. Millersen
Celia M. 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 : K021878
Device Name : ESKA Modular Total Hip System Acetabular Components
Indications For Use :
The ESKA Modular Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic 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 N Millmor
(Division Sign-Off) Division of General, Restorative and Neurological Devices
109(k) Number K021878