(207 days)
No
The document describes a ceramic femoral head for hip replacement, focusing on material composition, dimensions, and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is a ceramic femoral head intended for hip arthroplasty procedures to replace damaged joint components, which is a therapeutic intervention.
No
The device is a ceramic femoral head designed for surgical implantation in hip arthroplasty procedures, not for diagnosing medical conditions.
No
The device is a physical implant (femoral head) made of ceramic material, intended for mechanical fixation in hip arthroplasty. The description focuses on material composition, dimensions, and mechanical properties, with no mention of software.
Based on the provided text, 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 compatibility testing.
- Device Description: The description details the material (Zirconia-Toughened-Alumina Ceramic), physical characteristics (C-Taper bore, sizes), and intended function as a femoral head component in a hip replacement. This aligns with a medical device for implantation, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, this device is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
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 cementless hip arthroplasty procedures. The subject devices are single use devices. 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. .
- l Aseptic necrosis of the femoral head.
- u Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion,
- . Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- 에 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 I 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.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:
- . Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
- A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys, .
- a Sizes:
- 0 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.
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 demonstrated that the subject devices' mechanical properties were substantially equivalent to the predicate devices' mechanical properties.
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.
K971409, K991952, K003391, K031803
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
FEB 1 1 2005
510(k) Summary of Safety and Effectiveness for the ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX® DELTA) CERAMIC FEMORAL HEADS
| Proprietary Name: | Howmedica Osteonics Zirconia-Toughened-
Alumina (Biolox® Delta) Ceramic Femoral Heads |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Femoral Head Component |
| Classification Name and Reference: | Hip Joint, Metal/Ceramic/Polymer, Semi-
Constrained, Cemented or Nonporous Uncemented
Prosthesis, 21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 LZO |
| Official Contact: | Terry Sheridan Powell
Regulatory Affairs Team (Consultant)
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Phone: (201) 831-5493
Fax: (201) 831-6038
E-Mail: Terry.Powell@stryker.com) |
| Date Summary Prepared: | December 1, 2004 |
Predicate Devices
The predicate devices cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803.
Device Description
The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:
- . Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
1
- A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys, .
- a Sizes:
- 0 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.
Intended Use
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. The subject devices are single use devices. 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. .
- l Aseptic necrosis of the femoral head.
- u Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion,
- . Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- 에 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 I 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.
Substantial Equivalence:
Intended Use:
The subject devices share the identical indications for use as the cited predicate Howmedica Osteonics devices. The intended use for the predicate Howmedica Osteonics devices states that they can be used only with C-Taper hip stems made from Titanium alloy. The subject devices, however, can be used with C-Taper* hip stems made from CoCr or Titanium alloys. This is because the subject devices, made from ZTA ceramic, are stronger.
Design:
The subject devices feature the same design as the predicate Howmedica Osteonics devices. They feature the same C-Taper bore, and the same availability in 28mm, 32mm, and 36mm outer
- 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
diameters. The subject devices feature neck length options of -2.5mm, +0mm, +2.5mm, and +5mm (while the predicate devices feature neck length options of -5mm, -2.5mm, +0mm, and +5mm). The subject devices do not feature a new worst-case neck length option-all neck length options fall within the range of neck lengths already cleared for the predicate Howmedica Osteonics devices.
Material:
The subject devices are manufactured from ZTA ceramic material. One of the cited predicate devices is also manufactured from ZTA ceramic material.
Performance Data:
Mechanical testing demonstrated that the subject devices' mechanical properties were substantially equivalent to the predicate devices' mechanical properties.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a layered or overlapping manner.
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K041940
Trade/Device Name: Howmedica Osteonics Zirconia-Toughened-Alumina (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: II Product Code: LZO Dated: January 20, 2005 Received: January 21, 2005
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in in it is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for associated in the energy, 1976, the enactment date of the Medical Device Amendments or to commerce proc to May 20, 1978, is ecordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the act include requirements for annual registration, listing of devices, controls provisions or the received son prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device 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 r tease be devised had i termination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or any I edital 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 forth in the quilty by store (sions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Karen Ariemma
This letter will allow you to continue marketing your device as described in your Section 510(k) I mb lotter will and wy of substantial equivalence of your device of your device to a legally premated notificated 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 spocents acrioliance 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 other golferal milermational 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/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K041940
Device Name: ZTA Ceramic Femoral Heads________________________________________________________________________________________________________________________________________
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 polyethylene bearing surfaces.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, 해
- . Aseptic necrosis of the femoral head,
- Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations that indicate a more conservative I acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- 내 Salvage of failed total hip arthroplasty
Indications for Use as a Total Hip:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, 6 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 내 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
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ---------------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1of1__
510(k) Number. K041940