(72 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a ceramic femoral head for joint replacement. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is intended to treat a variety of medical conditions and reduce pain, which are therapeutic functions.
No
The device description and intended use indicate it is an orthopedic implant (femoral head) used for treatment and correction of conditions, not for diagnosing them.
No
The device description clearly describes a physical implantable device (a ceramic femoral head) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the surgical treatment of musculoskeletal conditions and injuries. These are procedures performed directly on the patient's body.
- Device Description: The device is described as a "Zirconia Ceramic Femoral Head," which is an implantable component used in joint replacement surgery.
- Anatomical Site: The device is intended for the "proximal femur," a part of the human skeleton.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
This device is clearly an implantable medical device used in surgical procedures, not an IVD.
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, 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal ട്. femur with head involvement, unmanageable using other techniques,
-
- treatment/reduce pain,
-
- treatment of osteomvelitis.
-
- endoprosthesis femoral osteotomy,
- റി. use determined by the physician using sound medical judgment.
Product codes
87LZO
Device Description
The Whiteside Biomechanics 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, femoral neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K964150
510(k) Statement
DEC 2 7 1996
Device:
Classification Name:
prosthesis, hip semiconstrained,metal, polymer, porous, uncemented
Classification No .: 87LZO Common/Usual Name: zirconia ceramic femoral head Proprietary Name: Whiteside Biomechanics Zirconia Ceramic Femoral Head
Manufacturer Identification:
Whiteside Biomechanics, Inc. 12634 Olive Blvd. Creve Coeur, MO 63141
Establishment Registration Number: 1932213
Device Description:
The Whiteside Biomechanics 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 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.
Intended 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, 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal ട്. femur with head involvement, unmanageable using other techniques,
-
- treatment/reduce pain,
-
- treatment of osteomvelitis.
-
- endoprosthesis femoral osteotomy,
- ರಿ. use determined by the physician using sound medical judgment.
Additional Information:
This femoral head is made from magnesia stabilized zirconia ceramic. The device is to 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.