(167 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a ceramic femoral head, with no mention of AI or ML technology.
Yes.
The device is used in total hip arthroplasty to treat severe hip pain and disability due to various medical conditions, directly addressing a medical problem.
No
Explanation: The device, the BIOLOX delta Ceramic Femoral Heads, is a modular component used in total hip arthroplasty to replace existing anatomical structures based on diagnosed conditions. It does not perform any diagnostic function such as identifying, detecting, or measuring a medical condition.
No
The device description explicitly states the device is fabricated from an alumina matrix composite and is available in various diameters and offsets, indicating it is a physical hardware component (femoral head) used in surgery, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a modular component for total hip arthroplasty (hip replacement surgery). This is a surgical procedure performed on a patient's body.
- Device Description: The description details a physical implantable component (femoral head) made of ceramic material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implantable medical device used inside the body during surgery.
N/A
Intended Use / Indications for Use
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Non-Clinical Performance and Conclusions: Mechanical testing was performed and results indicate that the BIOLOX delta Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Қ071535
Summary of Safety and Effectiveness
NOV 1 9 2007
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8354
Fax: (574) 372-4605 |
| Date: | June 4, 2007 |
| Trade Name: | BIOLOX ® delta* Ceramic Femoral Head |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Name and
Reference: | Hip joint metal/ceramic/polymer semiconstrained
cemented or nonporous uncemented prosthesis
21 CFR § 888.3353 |
| Predicate Device(s): | 36mm Biolox delta Ceramic Heads, manufactured
by Biomet, K061312, cleared June 6, 2006
DePuy Delta Ceramic Femoral Head, manufactured
by DePuy, K062748, cleared November 30, 2006
V40 TM Biolox delta Ceramic Femoral Heads,
manufactured by Howmedica Osteonics, K052718,
cleared October 27, 2005 |
| Device Description: | The BIOLOX delta Ceramic Femoral Heads are
fabricated from an alumina matrix composite and
are available in diameters of 28, 32, 36, and 40 mm
with a range of offsets to accommodate various
patient anatomies. They serve as an alternative to
both metal and alumina ceramic femoral heads for
use in total hip arthroplasty. |
- Trademark of CeramTec: AG
1
| Intended Use: | The BIOLOX delta Ceramic Femoral Heads are
modular components used in total hip arthroplasty
and indicated for the following: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Patients suffering from severe hip pain and
disability due to rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis, collagen disorders,
avascular necrosis of the femoral head, and
nonunion of previous fractures of the femur;
patients with congenital hip dysplasia, protrusio
acetabuli, or slipped capital femoral epiphysis;
patients suffering from disability due to previous
fusion; patients with previously failed
endoprostheses and/or total hip components in the
operative extremity; and patients with acute neck
fractures. |
| Comparison to Predicate Device(s): | The BIOLOX delta Ceramic Femoral Heads are
substantially equivalent to the femoral heads listed
above as predicate devices. Both the proposed and
predicate designs are intended to function as a
modular femoral head component in total hip
arthroplasty and are manufactured from the same
materials. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Mechanical testing was performed and results
indicate that the BIOLOX delta Ceramic Femoral
Heads are equivalent to devices currently on the
market and capable of withstanding in vivo loading. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for
this device. |
and the comments of the comments of
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. c/o Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
K071535 Trade/Device Name: Biolox® delta Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: October 25, 2007 Received: October 26, 2007
Dear Ms. Jenks:
Re:
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.
3
Page 2 -
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 logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliario at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsiblities 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 yours,
Mark N Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K071535
Indications for Use
510(k) Number (if known):
Device Name:
BIOLOX® delta* Ceramic Femoral Head
Indications for Use:
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed?
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sabara Cuchup
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K071535
*Trademark of CentuaTes AG