(30 days)
No
The summary describes a passive, mechanical implant (femoral head) and the testing performed is focused on mechanical properties and substantial equivalence to predicate devices, with no mention of AI/ML or related concepts.
Yes
The device is used to treat severe hip pain and disability due to various conditions, including rheumatoid arthritis, osteoarthritis, and fractures, which aligns with the definition of a therapeutic device.
No
The device description clearly states that the BIOLOX delta Ceramic Femoral Heads are "modular components used in total hip arthroplasty." This indicates they are an implantable device used in surgical procedures, not for diagnosing medical conditions.
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 heads for hip replacement).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used in total hip replacement surgery. It is a physical component (a femoral head) that is implanted into the patient's body.
- Lack of Diagnostic Testing: There is no mention of analyzing biological samples or performing any kind of diagnostic test. The device's function is purely mechanical and structural within the body.
Therefore, based on the provided information, the BIOLOX delta Ceramic Femoral Heads are a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
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
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
Non-clinical testing as well as engineering and risk analyses were performed to demonstrate substantial equivalence of the subject femoral heads to the predicate devices. The specific non-clinical testing and analyses completed include pull-off testing and range of motion analyses. Additionally, a fatigue strength analysis was completed to ensure the new combination does not present a new worst case compared to other legally marketed combinations. This information and testing results formed the basis for a determination of substantial equivalence. Clinical data and conclusions were not needed for this device.
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.
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K130899 (Page 1 of 2)
MAY 0 1 2013
2
Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with the letter "Z" inside of it. Below the circle is the word "zimmer" in lowercase letters.
. P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
510 (« ) Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Product Code / Device:
Regulation Number / Description:
Predicate Device:
Device Description:
Zimmer GmbH Sulzer Allee 8 Winterthur. CH-8404. Switzerland
Rebecca M. Brooks Sr. Specialist, Regulatory Affairs Telephone: (574) 371-8033 Fax: (574) 372-4605
April 30, 2013
BIOLOX delta Ceramic Femoral Heads
Ceramic Femoral Head Prosthesis
LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
21 CFR & 888.3353 - Hip joint metal/ceramic/ polymer semi-constrained cemented or nonporous uncemented prosthesis
BIOLOX delta Ceramic Femoral Heads, manufactured by Zimmer GmbH, K071535, cleared November 19, 2007
Avenir Müller Stem, manufactured by Zimmer GmbH, K123392, cleared March 4, 2013
Zimmer Porolock MIS Stem, manufactured by Zimmer GmbH, K071723, cleared March 7, 2008
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.
1
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical
and/or Clinical):
K130899 (Page 2 of 2)
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.
No changes are being made to the designs of the subject BIOLOX delta Ceramic Femoral Heads. The proposed modification is limited to expanding the scope of compatible femoral stems. The BIOLOX delta Ceramic Femoral Heads are sterilized using equivalent materials and processes as their predicates. The subject devices also have the same intended use and performance characteristics as their predicates.
Non-Clinical Performance and Conclusions:
Non-clinical testing as well as engineering and risk analyses were performed to demonstrate substantial equivalence of the subject femoral heads to the predicate devices. The specific non-clinical testing and analyses completed include pull-off testing and range of motion analyses. Additionally, a fatigue strength analysis was completed to ensure the new combination does not present a new worst case compared to other legally marketed combinations. This information and testing results formed the basis for a determination of substantial equivalence.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2013
Zimmer GmbH % Zimmer, Incorporated Ms. Rebecca M. Brooks Senior Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K130899
Trade/Device Name: BIOLOX® delta Ceramic Femoral Heads 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: March 29, 2013 Received: April 1, 2013
Dear Ms. Brooks:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Rebecca M. Brooks
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin Weith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130899 (pg 1/1)
Device Name:
BIOLOX® delta Ceramic Femoral Heads
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)
Elizabet标题 - Frank - S
Division of Orthopedic Devices
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