(87 days)
Not Found
Not Found
No
The summary describes a physical implant (femoral head) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a Ceramic Unipolar Femoral Head, which is an implant used for anatomical correction and replacement, rather than a device that delivers therapy.
No
The device description indicates it is a physical implant (femoral head) used for treatment/correction, not for diagnosing conditions.
No
The device description clearly states it is a "Ceramic Unipolar Femoral Head" composed of "magnesia partially stabilized zirconia (MG-PSZ)", which is a physical implantable component, 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 a device used within the body for surgical procedures related to joint disease and fractures. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device is a ceramic femoral head, a component of a joint replacement or repair. This is a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
This device is a surgical implant intended for use in orthopedic procedures.
N/A
Intended Use / Indications for 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,
- revision procedures where other treatments or devices have failed, and 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Not Found
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.
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
510(k) SUMMARY
87LZO
femoral head
NOV 2 4 1997
Device:
Classification Name:
Prosthesis, Hip, Semi-constrained, Metal /Ceramic/Polymer, Cemented or Non-porous Uncemented
Classification No .: Common / Usual Name:
Proprietary Name:
Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head
Manufacturer Identification:
Whiteside Biomechanics, Inc. 12634 Olive Blvd. St. Louis, MO 63141
Establishment Registration Number: 1932213
Device Description:
The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.
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,
- revision procedures where other treatments or devices have failed, and 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
Additional Information:
This femoral component is composed of magnesia partially stabilized zirconia (Mg-PSZ). This device will be supplied double pouched and sterilized by 100% ethylene oxide (ETO) with nitrogen. The outer and inner package labels will include a sterilization indicator that changes color with exposure to the sterilant.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands resembling a double helix, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is positioned to encircle the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 1997
Mr. Michael C. Wall Official Correspondent Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141
K973261 Re : Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head Regulatory Class: II Product Code: LZO August 25, 1997 Dated: Received: August 29, 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 qeneral controls provisions of the Act and the following limitation that the package insert must reflect that the Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the Whiteside Biomechanics, Inc. 12/14 taper trunnions.
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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
2
Page 2 - Mr. Michael C. Wall
Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 Requlations.
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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be 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,
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) Number (if known):
K973261_
Device Name: CERAMIC UNIPOLAR FEMORAL HEAD
Noninflammatory degenerative joint disease, Indications For Use: 1. including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis 2.
-
- Correction of functional deformity
- Revision procedures where other treatments 4 . or devices have failed.
- Treatment of non-unions, femoral neck, and 5. trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of General Restorative Devices, & 73211 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
510(k) Number.
(Optional Format 1-2-96)