(82 days)
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Not Found
No
The document describes a ceramic femoral head implant and its intended uses, with no mention of AI or ML technology in the device description or other sections.
Yes
The device is a ceramic femoral head, an implantable component for joint replacement surgery, which is a therapeutic intervention for conditions like osteoarthritis and rheumatoid arthritis.
No
The device description and intended use outline its function as an implant for joint replacement and bone treatment, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (a ceramic femoral head) and its intended use in surgical procedures, indicating it is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "Zirconia Ceramic Femoral Head" intended for surgical implantation to treat various conditions of the hip joint (proximal femur). This is an implantable medical device, not a diagnostic test performed on a sample outside the body.
The intended uses listed are all related to surgical procedures and the treatment of musculoskeletal conditions, not the analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
This device is intended to be used for:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- rheumatoid arthritis
- correction of functional deformity
- revision procedures where other treatments or devices have failed
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- treatment of osteomyelitis
- endoprosthesis femoral osteotomy
- use with a polyethylene cup with or without metal backed shell.
Product codes
LZO
Device Description
The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.
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
Femur, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael C. Wall, RN Official Correspondent Whiteside Biomechanics 12634 Olive Boulevard St. Louis, Missouri 63141
JUL 30 1997
K971721 Re :
Whiteside Biomechanics Zirconia Ceramic Femoral Head (Sizes 22mm 0, 22mm +3.5, 26mm -3.5) Regulatory Class: II Product Code: LZO Dated: May 8, 1997 Received: May 9, 1997
Dear Mr. Wall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Whiteside Biomechanics Zirconia Ceramic Femoral Head is to only be used with the Whiteside Biomechanics 12/14 taper made from wrought titanium alloy. This information must be identified in the package insert.
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.
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Page 2 - Michael C. Wall, RN
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of -----Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Michael C. Wall, RN
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Summary
K97172/
Device:
Classification Name:
prosthesis, hip semiconstrained,metal, polymer, porous, uncemented
| Classification No.: | 87LZO |
|---|---|
| Common/Usual Name: | zirconia ceramic femoral head |
| Proprietary Name: | Whiteside Biomechanics,Inc. Zirconia |
| Ceramic Femoral Head |
Manufacturer Identification:
Whiteside Biomechanics, Inc. 12634 Olive Blvd. Creve Coeur, MO 63141
1932213 Establishment Registration Number:
Device Description:
The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.
Intended Use:
This device is intended to be used for:
- noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis
-
- rheumatoid arthritis
- correction of functional deformity 3.
- revision procedures where other treatments or devices have failed 4.
-
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
-
- treatment of osteomyelitis
-
- endoprosthesis femoral osteotomy
Additional Information:
This femoral head is made from magnesia stabilized zirconia ceramic. The device will be sterilized with 100% ethylene oxide in nitrogen according to the AAMI guidelines for sterilization. Resterilization of femoral heads upon contamination is not recommended. DO NOT RESTERILIZE.
4
STOMECHAN ICAL
ge a
510(k) Number (if known):
K971721
Whiteside Biomechanics Inc. Zirconia Ceramic Femoral Head Device Name:__
Indications For Usc:
- 1 . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, -------
-
- rheumatoid arthritis,
-
- correction of functional deformity,
-
- correction of functional detormats or devices have failed,
- revision procedures where other treatments or devices of
- 4 . revision procedures when acaded and tochanterials of the proximal
5 . treatment of non-unions, femoral neck and tochanterial proximal treatment of non-unfolis, temoral nook and cousiness of ther techniques,
femur with head involvement, unmanageable using other techniques, -
- treatment of osteomyclitis,
- 7 . endoprosthesis femoral osteotomy.
- 7 . endoprosthesis remoral osteolomy :
8 . use with a polyethylene cup with or without metal backed shell.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Offm
Division of General Restorative Devices K971721
510(k) Number
Prescription Use (Pcr 21 CFR 801.109) ાર
Over-Thic-Counter Use_
(Options) Formal 1-2-96)
F.03