(28 days)
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Not Found
No
The document describes a ceramic femoral head for hip replacement and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for treating painful disabling joint disease of the hip, femoral head/neck fractures, and aseptic necrosis of the femoral head, which are therapeutic interventions.
No.
The device is a ceramic femoral head, which is an implantable prosthetic component for hip replacement surgery, not a diagnostic tool. Its intended use is to replace diseased or damaged hip joints, not to diagnose medical conditions.
No
The device description clearly states it is a ceramic femoral head, which is a physical implant, 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 component for hip replacement surgery, addressing painful disabling joint disease, fractures, and other hip conditions. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a ceramic femoral head that mates with femoral stems. This is a physical component used in surgery.
- 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 screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures .
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. .
- Asceptic necrosis of the femoral head. .
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty .
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
The subject V40" Biolox® delta Ceramic Femoral Heads mate with Howmedica Osteonics' V40™ taper femoral stems fabricated from Titanium, CoCr or stainless steel alloys. The V400 Biolox® delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
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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
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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. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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 Alumina V40 Ceramic Femoral Heads
7 2005
510(k) Summary of Safety and Effectiveness Line Extension to the Alumina V40" Ceramic Femoral Heads
| Proprietary Name: | V40™ 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: | September 28, 2005 |
Device Description
The subject V40" Biolox® delta Ceramic Femoral Heads mate with Howmedica Osteonics' V40™ taper femoral stems fabricated from Titanium, CoCr or stainless steel alloys. The V400 Biolox® delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.
Device Modification
This submission modifies the material of the Alumina V40™ Ceramic Femoral Heads from alumina to Zirconoia Toughened Alumina (ZTA) and adds additional offsets of 28 and 36mm diameter heads.
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1
Indications for Use
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures .
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. .
- Asceptic necrosis of the femoral head. .
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty .
Substantial Equivalence
The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use 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, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
Karen Ariemma Senior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
Re: K052718
RUS2110
Trade/Device Name: V40™ Biolox® delta Ceramic Femoral Heads (Line Extension to the Alumina V40™ 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: September 28, 2005 Received: September 29, 2005
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b re(a) Fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enoropare) to regars the Medical Device Amendments, or to commerce price to May 20, 1978, the exacted with the provisions of the Federal Food, DNAA devices mat have been recalism in accessariou of a premarket approval application (PMA). alle Cosmetic Acr (71ct) that do not requestly subject to the general controls provisions of the Act. The I ou may, therefore, manel are act include requirements for annual registration, listing of general controls provisions of uactice, 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 n your device is classified (500 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and chick on FD may be subject to subli additions, Title 21, Parts 800 to 898. In addition, I'DA may be found in the Court of ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease be advised that 1 Dri 3 ilsualles or our device complies with other requirements of the Act that I DA has made a acterimantions administered by other Federal agencies. You must of any I cueral statutes and regalations and limited to: registration and listing (21
3
Page 2 - Ms. Karen Ariemma
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), idocing (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 510(k) I his letter will anow you to ocgin manceing your are of your device of your device to a legally premarket nother 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 If you desire specific advice for your 2001) 276-0120. Also, please note the regulation entitled, comact the Office of Comphalled at (217) = 16 = 18 = 1 = 1 807.97). You may obtain Misolanung by reference to premantontibilities under the Act firsm the Division of Small other gelleral information on your respenser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octisa.http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Mark N. Melasky, III
Ser Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Biolox® delta V40™ Ceramic Femoral Heads
The indications for use of the subject device, in keeping with those of other legally marketed The Indications 10-10-11-2017 ceramic femoral bearing heads are as follows:
For Use as a Total Hip Replacement:
- Ose as a Total Inp its places of the hip resulting from: degencrative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures .
- Revision of provious oup alems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. .
- Asceptic necrosis of the femoral head. .
- Asception necrosis of we post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative . I acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of of 1 -
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________