(27 days)
Not Found
No
The summary describes a mechanical implant (femoral head) and its intended uses and mechanical testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a ceramic femoral head used in hip arthroplasty procedures, which are medical interventions designed to treat painful disabling joint disease, fractures, and other pathological conditions of the hip, thus providing therapy to the patient.
No
The device is described as a single-use mechanical fixation device for hip arthroplasty, and its intended use and description pertain to surgical implantation, not diagnosis.
No
The device description clearly indicates it is a physical implant (ceramic femoral heads) intended for mechanical fixation in hip arthroplasty, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for mechanical fixation in hip arthroplasty procedures. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a ceramic femoral head designed to mate with hip stems. This is a physical component of a medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used in hip replacement procedures.
N/A
Intended Use / Indications for Use
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, .
- Aseptic necrosis of the femoral head, .
- . Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty.
Indications for Use as a Total Hip:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.
- The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032.
Product codes
87 LZO
Device Description
The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.
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)
Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength.
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.
Not Found
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.
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
Line Extension to the Biolox® Delta Ceramic Femoral Heads
K05/588
1/3
JUL 1 2 2005 510(k) Summary of Safety and Effectiveness
Line Extension to the Biolox® Delta Ceramic Femoral Heads
| Proprietary Name: | Biolox® Delta Ceramic Femoral Heads |
|---|---|
| Common Name: | Artificial femoral head component |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis, 21 CFR §888.3353. | |
| Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained, |
| Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented | |
| For Information contact: | Karen Ariemma, Senior Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: karen.ariemma@stryker.com | |
| Date Summary Prepared: | June 13, 2005 |
Device Description
The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.
Device Modification
This submission adds additional femoral heads (36 mm diameter -5.0 mm offset heads and 36 mm diameter +7.5 mm offset heads) and allows for use of the Biolox® Delta Ceramic Femoral Heads with the Trident® X3™ Acetabular inserts.
1
Line Extension to the Biolox® Delta Ceramic Femoral Heads
21
Indications for Use
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, .
- Aseptic necrosis of the femoral head, .
- . Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty.
Indications for Use as a Total Hip:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.
- The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032.
2
88
Substantial Equivalence
The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.
JUL 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Senior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Received: June 15, 2005
Re: K051588
Trode/Device Name: Line Extension to 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: June 13, 2005
Dear Ms. Ariemma:
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.
4
Page 2 - Ms. Karen Ariemma
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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Erle M
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Biolox® Delta Ceramic Femoral Heads
The subject devices are single use devices. They are intended for mcchanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, ■
- 트 Aseptic necrosis of the femoral head,
- 트 Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- b Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty.
Indications for Use as a Total Hip:
- Painful disabling joint discase of the hip resulting from: degenerative arthritis, rheumatoid 미 arthritis, post-traumatic arthritis or late stage avascular necrosis,
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- i Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
- .. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acctabulum.
- The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032
Prescription Use X - -AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Ola
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Civision Sin -Off Division of Conneral, Restorative and Neurolo, Joal Devices
051588