(47 days)
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No
The document describes a mechanical orthopedic implant (femoral heads and sleeves) and its intended use in hip arthroplasty. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is a femoral head used in hip arthroplasty procedures to replace diseased or damaged joints, which is a therapeutic intervention.
No
This device is described as a "femoral head" intended for "mechanical fixation to their mating hip stems" in "hip arthroplasty procedures," indicating it is an implantable prosthetic device, not a diagnostic tool.
No
The device description clearly describes physical components (femoral heads, metal sleeves) made of materials like ceramic, titanium, and cobalt chrome, intended for mechanical fixation in hip arthroplasty. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device for mechanical fixation within the human body during hip arthroplasty procedures. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical implant (femoral heads and metal sleeves) designed to be surgically placed in the hip joint.
- 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 falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject devices are sterile, single use devices. The Universal Taper Biolox delta femoral heads and metal adaptor sleeves can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or Cobalt Chrome alloys. The stainless steel metal adaptors are can be used with all Howmedica Osteonics stainless steel stems. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO, 87 LPH, 87 MEH, 87 JDI
Device Description
The Howmedica Osteonics Biolox delta ceramic femoral heads will now be available in a universal taper with available metal sleeves which accommodate C-taper® and V40® taper femoral stems. The modified ceramic femoral heads will be available in diameters from 28mm to 44mm. The metal sleeves will be available in a variety of 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
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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.
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
MAY 16 2007
510(k) Summary of Safety and Effectiveness for the Universal Taper Delta Femoral Head
Proprietary Name:
Common Name:
Classification Name and Reference
Universal Taper Delta Femoral Head
1/2
Hip Prosthesis
Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous Uncemented Prosthesis 21 CFR §888.3353
Regulatory Class:
Device Product Code:
Class II
87 LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
87 LPH - Prosthesis Hip, Semi-Constrained, Porous Coated, Uncemented
87 MEH - Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
87 JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented
For Information contact:
Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5612 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers(@stryker.com
Date Summary Prepared:
May 11, 2007
1
K0700855
2/2
Device Description
The Howmedica Osteonics Biolox delta ceramic femoral heads will now be available in a universal taper with available metal sleeves which accommodate C-taper® and V40® taper femoral stems. The modified ceramic femoral heads will be available in diameters from 28mm to 44mm. The metal sleeves will be available in a variety of offsets.
Intended Use:
The subject devices are sterile, single use devices. The Universal Taper Biolox delta femoral heads and metal adaptor sleeves can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or Cobalt Chrome alloys. The stainless steel metal adaptors are can be used with all Howmedica Osteonics stainless steel stems. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.
Indications for Use
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, 미
- 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 conservative I acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- 트 Salvage of failed total hip arthroplasty.
Indications for Use as a Total Hip:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, I 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 в techniques are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive 트 techniques as indicated by deficiencies in the acetabulum.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corporation % Ms. Tiffiani D. Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432
MAY 16 2007
Re: K070885
Trade/Device Name: Universal Taper Delta Femoral Head 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: March 29, 2007 Received: March 30, 2007
Dear Ms. Rogers:
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. Iisting 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 mav 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
3
Page 2 - Ms. Tiffani Rogers
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mello
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Ko7(2885
Device Name: Universal Taper Delta Femoral Head
Indications for Use
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, ●
- 피 Aseptic necrosis of the femoral head,
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular l involvement or distortion,
- Pathological conditions or age considerations that indicate a more conservative acetabular 피 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 트 arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other 트 procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are 트 less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as 트 indicated by deficiencies in the acetabulum.
× Prescription Use
OR (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yaubara Suekoff
(Division Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number K070885