(187 days)
No
The device description and performance studies focus on the mechanical properties and materials of a ceramic hip implant component, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a modular femoral component used in total hip replacement, which is a medical procedure aimed at treating various hip conditions, thereby providing therapeutic benefits to the patient.
No
The device description clearly states that TGM Bioolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty, and the intended use describes their application in total hip replacement for various conditions. These are treatment-oriented applications, not diagnostic ones.
No
The device description clearly states it is a modular femoral component made of ceramic material, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant used in total hip replacement surgery. It is a physical component that is placed inside the body to replace a damaged hip joint.
- Intended Use: The intended use clearly states that the device is for use in total hip replacement to address various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a Class III medical device (based on the predicate devices and the nature of the implant), which is a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Product codes
LZO
Device Description
The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing suggests that the subject Biolox® delta Ceramic Heads perform adequately in burst testing, fatigue testing, post fatigue burst testing, rotational stability and pull-off testing. Previously conducted testing (i.e., proximal and distal fatigue, fretting/corrosion and RoM) were also evaluated using the new ceramic heads and the results were found to be acceptable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
September 9, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TGM Medical, Incorporated % Kellen Hills. Senior Regulatory Consultant Orchid Design, A Division of Orchid Orthopedic Solutions 4600 E Shelbv Drive Memphis TN 381188
Re: K150576 Trade/Device Name: TGM Biolox® delta Ceramic 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: July 30, 2015 Received: August 07, 2015
Dear Mr. Hills:
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 (21CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150576
Device Name TGM Biolox® delta Ceramic Heads
Indications for Use (Describe)
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic
arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Sum Required by 21 CFF
(a)(1) Submitted By: TGM Medical, Inc 5145 Golden Foothill Parkway El Dorado Hills, CA 95762 Phone: 916-292-8502 July 30, 2015 Date: Contact Persons Primary: Kellen Hills (Orchid Design Consulting) Secondary: Gordon Smith (TGM Medical, Inc) Proprietary Name: Biolox® delta (a)(2) Common Name: Ceramic Femoral Head Classification Name and Reference: 21CFR 888.3353 – Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Product Code: LZO
Biomet Biolox® delta Heads (K131684) Depuy Biolox® delta Heads (K031803/K040644) TGM Helicon/Zenith Total Hip Systems (K111472/K121636)
Predicate Devices:
(a)(3)
- Device Description: (a)(4)
The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.
The purpose of this submission is to gain initial marketing authorization in the United States.
-
(a)(5) Indications for Use:
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of: -
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
-
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
-
C. Proximal femoral fractures.
-
D. Avascular necrosis of the femoral head.
-
E. Non-union of proximal femoral neck fractures.
4
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
- (a)(6) Comparison of Technological Characteristics:
The subject Biolox® delta Ceramic Heads are being compared to the predicates Biomet Biolox® delta Heads and Depuy Biolox® delta Heads which were cleared under K131684 and K031803/K040644, respectively. The subject and predicate devices are equivalent in terms of intended use, indications for use, material, design and dimensions.
Additional predicates include the TGM Medical Helicon and Zenith Total Hip Systems, K111472 and K121636, respectively. These systems are being used as predicates for their mating components, indications and worst case bench testing constructs.
-
Non-clinical testing: (b)(1)
Performance testing suggests that the subject Biolox® delta Ceramic Heads perform adequately in burst testing, fatigue testing, post fatigue burst testing, rotational stability and pull-off testing. Previously conducted testing (i.e., proximal and distal fatigue, fretting/corrosion and RoM) were also evaluated using the new ceramic heads and the results were found to be acceptable. -
Clinical testing: (b)(2) Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
-
(b)(3) Conclusions:
Based on the information provided in this premarket notification and the details specified in FDA draft guidance document "Ceramic Ball 510(k)s" issued January 10, 1995, we believe that the subject TGM Medical Biolox® delta Ceramic Heads are substantially equivalent to the predicate devices.