(79 days)
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip replacement component, used in total or partial hip replacement procedures to alleviate pain and disability. This aligns with the definition of a therapeutic device as it treats a medical condition.
No
The document describes a hip stem and ceramic hip head, which are prosthetic implants used in hip replacement surgery to treat structural damage. These devices are therapeutic, not diagnostic.
No
The device description explicitly states the components are manufactured using cobalt-chromium-molybdenum alloy and Yttrium Stabilized Zirconium Oxide, indicating it is a physical medical device, not software-only.
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 surgical implant for replacing parts of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials used for the hip stem and head, which are components of a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are designed to perform tests on these types of samples.
The device is a surgical implant used in hip replacement procedures.
N/A
Intended Use / Indications for Use
The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA).
The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.'s femoral stems with a 12/14 Morse-type taper.
Product codes
Not Found
Device Description
All Hip Stem components are manufactured using cobalt-chromium-molybdenum alloy that complies with ASTM F799. The Ceramic Hip Head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
The test results obtained for the Ceramic Hip Head exceed the requirements of the Guidance Document ("Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"-Draft, January 10, 1995).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 29 1988
EXHIBIT III
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
P.F.C. Ceramic Hip Head indicated for use with the P.F.C. Cemented Hip Stem, Ultima Cemented Hip Stem and Ultima Cemented Long Stem
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Contact Person 1.
Anne M. Griffin, Regulatory Affairs Specialist, (508) 828 - 3107.
Name of Device 2.
P.F.C. Ceramic Hip Head indicated for use with the P.F.C. Cemented Hip Stem, Ultima Cemented Hip Stem and Ultima Cemented Long Stem. The P.F.C. Ceramic Hip Head has been cleared under 510(k) K933275.
3. Device Classification
Ceramic Hip Heads have been placed into Class II by 21 CFR 888.3353.
Statement of Substantial Equivalence 4.
The Ceramic Hip Heads and the Cemented Hip Stems are identical in design, materials and indications for use to those already cleared for domestic commercial distribution. This Premarket Notification is for the labeling of the Hip Stems for use with the Ceramic Hip Head. The mating of the Co-Cr-Mo alloy trunnion of the Hip Stems does not alter the safety and effectiveness of the devices. The test results obtained for the Ceramic Hip Head exceed the requirements of the Guidance Document ("Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"-Draft, January 10, 1995).
5. Indications for Use
The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA).
The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.'s femoral stems with a 12/14 Morse-type taper.
Physical Description 6.
All Hip Stem components are manufactured using cobalt-chromium-molybdenum alloy that complies with ASTM F799. The Ceramic Hip Head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®