(485 days)
No
The summary describes a mechanical implant (femoral component) and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is a P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, which is used in total and partial hip replacement procedures to alleviate pain and disability, making it a therapeutic device.
No
This device is a prosthetic implant (Total Hip System Femoral Component) used in hip replacement procedures, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "Porous Coated Modular Femoral Component" manufactured from titanium alloy, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant - a femoral component for a total hip replacement. This device is physically placed inside the patient's body to replace a damaged part of the hip joint.
- Intended Use: The intended use clearly states it's for "total and partial hip replacement procedures" to address structural damage and conditions affecting the hip joint. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided about the device's material, sizes, and indications for use are all consistent with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).
Product codes
Not Found
Device Description
The P.F.C. 2 Total hip System Porous Coated Femoral Component in the smaller sizes is manufactured from titanium alloy (Ti-6A1-4V), the same material used to manufactured the P.F.C. 2 femoral components in the larger sizes. In addition to the sixteen sizes available under premarket notification #K935452, five additional sizes are available; three standard sizes (1/1, 2/2, and 3/3) and two additional sizes (2/1 and 3/2) to accommodate patient populations with proximal to distal incongruity.
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)
Not Found
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
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
K 345518
MAR - 8 1955
EXHIBIT I
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component - Smaller Sizes
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
CONTACT PERSON 1.
J. Teresa Dorriety, Esq., Sr. Regulatory Affairs Specialist, (508) 880-8404
NAME OF DEVICE 2.
Proprietary Name: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component Common Name: Porous Coated Modular Femoral Prosthesis Classification Name: Hip Joint Metal/Polymer Semi-Constrained
3. DEVICE CLASSIFICATION
Classification for porous coated modular femoral prosthesis has been placed in Class II by FDA (58 FR 3227, January 9, 1993).
STATEMENT OF SUBSTANTIAL EQUIVALENCE 4.
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component in the smaller sizes is substantially equivalent and identical in function to the P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component cleared for commercial distribution under premarket notification #K935452.
న్ INDICATIONS FOR USE
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.
The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).
6. PHYSICAL DESCRIPTION
The P.F.C. 2 Total hip System Porous Coated Femoral Component in the smaller sizes is manufactured from titanium alloy (Ti-6A1-4V), the same material used to manufactured the P.F.C. 2 femoral components in the larger sizes. In addition to the sixteen sizes available under premarket notification #K935452, five additional sizes are available; three standard sizes (1/1, 2/2, and 3/3) and two additional sizes (2/1 and 3/2) to accommodate patient populations with proximal to distal incongruity.