(27 days)
Not Found
No
The document describes physical components for hip replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device, a ceramic femoral head, is a modular component used in total hip arthroplasty to treat severe hip pain and disability due to various medical conditions, indicating its direct role in alleviating symptoms and restoring function.
No
Explanation: The device is described as a modular component used in total hip arthroplasty (hip replacement surgery) for patients with various debilitating hip conditions. It is a prosthetic implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states that the device is fabricated from an alumina matrix composite and includes physical components like ceramic heads and a titanium adapter. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the BIOLOX delta and BIOLOX OPTION Ceramic Femoral Heads as implantable components used in total hip arthroplasty. They are surgically placed within the body to replace damaged parts of the hip joint.
- Lack of Specimen Analysis: There is no mention of these devices being used to analyze any biological specimens. Their function is mechanical and structural within the body.
Therefore, based on the provided information, these devices are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, 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.
• Patients with acute femoral neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, 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.
• 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 40mm 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.
The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision 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)
Results from engineering analyses demonstrate that the subject BIOLOX delta and BIOLOX OPTION ceramic femoral heads for which the expansion of product compatibility is proposed remains substantially equivalent to the predicate devices cleared under K071535 and K130899 (BIOLOX delta) and K073567 (BIOLOX OPTION) respectively. This conclusion has been supported by rationales for wear justification (ISO 7206-2), material equivalence (ISO 6474-2, ISO 5832-3/ASTM F136) and Range of Motion according to ISO 21535.
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
October 1, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zimmer GmbH Neha Sreenath Regulatory Affairs Senior Speicalist Sulzerallee 8 Winterthur, 8404 Ch
Re: K192416
Trade/Device Name: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System 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: August 30, 2019 Received: September 4, 2019
Dear Neha Sreenath:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K192416
Device Name
BIOLOX® delta Ceramic Femoral Head
Indications for Use (Describe)
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, 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.
· Patients with acute femoral neck fractures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K192416
Device Name
BIOLOX® OPTION Ceramic Femoral Head System
Indications for Use (Describe)
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, 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.
- · Patients with acute neck fractures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise."
510(k) SUMMARY
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neha Sreenath
Senior Specialist, Regulatory Affairs
Telephone: +41 58 85 48814
Fax: + 41 52 244 86 58 |
| Date: | August 30, 2019 |
| Trade Name: | BIOLOX® delta Ceramic Femoral Head
BIOLOX® OPTION Ceramic Femoral Head System |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Product Code : | LZO |
| Device Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,
Cemented Or Non-Porous, Uncemented
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous
Uncemented
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Regulation Number / Description: | 21 CFR § 888.3353 - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis |
| Predicate Device: | Biolox Delta Ceramic Femoral Heads, manufactured by Zimmer GmbH, K071535, cleared 11/19/2007 and K130899, cleared 05/01/2013
Biolox Option Ceramic Femoral Head System, manufactured by Zimmer GmbH, K073567, cleared 03/13/2008 |
| 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 40mm 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.
The BIOLOX OPTION Ceramic Femoral Head System consist of a
ceramic head fabricated from an alumina matrix composite
available in diameters of 28, 32, 36, and 40 mm and a titanium |
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Image /page/5/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise."
adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty. Indications for Use: BIOLOX delta Ceramic Femoral Heads: The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are 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. · Patients with acute femoral neck fractures. BIOLOX OPTION Ceramic Femoral Head System: The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is 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. · Patients with acute neck fractures. Comparison to Predicate Device: The intended use of the modified devices, as described in its labelling, has not changed as a result of the modifications proposed in the present submission. Further, the indications for use, materials, design features and sterilization method of the subject devices remain identical to the predicate devices. The proposed compatibility extension does not alter the fundamental scientific technology shared by both the subject devices and predicate devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions:
6
Image /page/6/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller, lighter gray font.
| and/or Clinical): | Results from engineering analyses demonstrate that the subject
BIOLOX delta and BIOLOX OPTION ceramic femoral heads for
which the expansion of product compatibility is proposed remains
substantially equivalent to the predicate devices cleared under
K071535 and K130899 (BIOLOX delta) and K073567 (BIOLOX
OPTION) respectively. This conclusion has been supported by
rationales for wear justification (ISO 7206-2), material equivalence
(ISO 6474-2, ISO 5832-3/ASTM F136) and Range of Motion
according to ISO 21535.
Clinical Performance and Conclusions: |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and indications
for use as the predicate devices. The subject devices use the
same operating principle, incorporate the same basic design and
labelling and are manufactured and sterilized using the same
materials and processes as the predicate devices. |
| | Except for the modifications described in this submission, the
subject devices are identical to the predicate devices, and the
performance data and analyses demonstrate that:
• any differences do not raise new questions of safety and
|
- effectiveness as established with performance testing; and
- the subject devices are at least as safe and effective as ● the legally marketed predicate devices.