(47 days)
No
The 510(k) summary describes a mechanical implant (acetabular cup system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is an acetabular cup system intended for permanent implantation in the hip joint to address various forms of arthrosis and other conditions, which is a therapeutic intervention.
No
The device is an acetabular cup system intended for surgical implantation to replace a damaged hip joint, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is a "non-cemented acetabular cup system" with physical components like "poly inserts," "acetabular screws," and "screw hole covers," indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or revising the hip joint. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details components of a hip replacement system (acetabular cup, inserts, screws). These are physical implants, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Product codes
MEH, LWJ, LZO, LPH
Device Description
The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femoral head
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
Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
KU71583
| Contact: | Mr. Mohan Emmanuel, President
Implants International, Ltd..
71 Jay Avenue
Teeside Industrial Est.
Thornaby-On-Tees
United Kingdom T517 9LZ
Telephone: 011-44-78433-80023
Email: mohan.emmanuel@implantsinternational.com | JUL 25 2007 | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|
| Trade name: | CER-MET™ III Acetabular Cup System | | | |
| Common name: | Acetabular Cup | | | |
| Classification
name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis | | | |
| | Hip joint metal/polymer/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis | | | |
| Regulation
number: | 21 CFR 888.3358 - Class II, Orthopedic Device Panel 87 | | | |
| | 21 CFR 888.3353 - Class II, Orthopedic Device Panel 87 | | | |
| Product Code: | MEH, LWJ, LZO, LPH | | | |
| Device
Description and
Characteristics: | The CER-MET™ III Acetabular Cup System is a non-cemented
acetabular cup system with a complete assortment of neutral and 10°
hooded poly inserts as well as acetabular screws and screw hole
covers (screw hole occluders). | | | |
| Equivalence: | The CER-MET™ III Acetabular Cup System is equivalent to other
legally marketed acetabular cup systems in design, materials and
intended use. Equivalent devices include the: | | | |
| | Trident® "T' Acetabular Shells marketed by Stryker Orthopaedics
(K040412 - S/E May 25, 2004) | | | |
| Indications: | The CER-MET™ III Acetabular Cup System is intended for
uncemented use for all types of arthrosis, such as advanced
destruction of the hip joint due to degenerative, post-traumatic or
rheumatoid arthritis, fracture or avascular necrosis of the femoral
head, sequelae of previous operations, such as internal fixation, joint
reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.
The same considerations apply to acetabular revisions. | | | |
| Performance
data: | Biomechanical tests have been performed. The test results were
equivalent to other similar implants and are sufficient for in vivo
loading. | | | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Implants International % Turnkey Intergration, Inc. Mr. Carl Knobloch 5349 Red Leaf Court Ovieda, FL 32765
JUL 25 2007
Re: K071583 Trade/Device Name: CER-MET® III Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MEH, LWJ, LZO, LPH Dated: April 16, 2007 Received: June 8, 2007
Dear Mr. Knobloch:
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.
2
Page 2 – Mr. Carl Knobloch
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 (240) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
510(k) Number:
Device Name(s):
CER-MET™ III Acetabular Cup System
Indications for Use:
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Prescription Use X
AND/OR
Over-The-Counter-Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karlene Bowen
Division of G Restorative. and Neurological Devices
510(k) Number K07158
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