(379 days)
P.F.C. * Uni-compartmental Knee System
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No
The summary describes a mechanical knee implant and its materials, with no mention of software, algorithms, or any technology that would suggest AI/ML. The performance studies focus on mechanical properties.
Yes.
The device is a knee replacement system intended to alleviate severe pain and disability caused by degenerative arthritis or osteochondritis dissecans, which are therapeutic interventions.
No
The device described is a uni-compartmental knee replacement system, which is a prosthetic implant used for treatment (replacement of a damaged knee joint), not for diagnosing a condition.
No
The device description clearly states it is a knee replacement system consisting of physical components made of metal alloys and polyethylene, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "uni-compartmental knee replacement" for treating pain and disability due to arthritis and osteochondritis dissecans. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the materials and components of a knee implant (femoral component, tibial component). This is consistent with a medical device implanted in the body, not an IVD.
- No mention of biological samples: There is no mention of the device interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Anatomical Site: The anatomical site is the "Knee joint," indicating it's used directly on or within the body.
Therefore, the P.F.C.® Σ Uni-compartmental Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The P.F.C.® Σ Uni-compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.
Product codes
Not Found
Device Description
The P.F.C. ® T Uni-compartmental Knee System is a uni-compartmental knee replacement consisting of a femoral component of cobalt-chromium-molybdenum alloy, and either an allplastic tibial component of ultra-high molecular weight polyethylene, or an alternative modular tibial component comprised of a titanium-6 aluminum-4 vanadium alloy tray with a modular UHMWPE insert.
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
Knee joint, femoral-tibial uni-compartmental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following testing was carried out for a determination of substantial equivalence:
Surface Finish Analysis
Tibial Insert and Tibial Tray Interlock Testing
Femoral-Tibial Contact Area Analysis
Contact Stress Calculation
Key Metrics
Not Found
Predicate Device(s)
P.F.C. * Uni-compartmental Knee System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
OCT 1 0 1996
K954481
EXHIBIT 1
510(k) SUMMARY
ﻳﺴﺒﺐ ﺍ
P.F.C.® > Uni-compartmental Knee System
Johnson and Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person
Anne M. Griffin, Associate Regulatory Affairs Specialist, (508) 828 - 3107.
2. Name of Device
| Proprietary Name: | P.F.C. Σ Uni-Compartmental Knee System |
|---|---|
| Common Name: | Unicompartmental Knee Prosthesis |
| Classification Name: | Knee joint Femorotibial metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II by 21 CFR §888.3530 |
3. Device Classification
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis has been placed into Class II by FDA (21 CFR §888.3530).
4. Substantial Equivalence
The P.F.C. E Uni-Compartmental Knee System is substantially equivalent in design, materials and principle of operation to the P.F.C. * Uni-compartmental Knee System currently marketed by Johnson and Johnson Professional, Inc. The test data indicate that the modified device, the P.F.C.® E Knee system, is substantially equivalent to the predicate device. The materials used conform to ASTM standards.
5. Indications for Use
The P.F.C.® Σ Uni-compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.
Image /page/0/Picture/16 description: The image contains a series of characters that appear to be handwritten. The characters are dark and bold, contrasting with the lighter background. The characters are '600 012'.
1
6. Physical Description - - - - - - - --------
The P.F.C. ® T Uni-compartmental Knee System is a uni-compartmental knee replacement consisting of a femoral component of cobalt-chromium-molybdenum alloy, and either an allplastic tibial component of ultra-high molecular weight polyethylene, or an alternative modular tibial component comprised of a titanium-6 aluminum-4 vanadium alloy tray with a modular UHMWPE insert.
7. Technological Characteristics as compared to Predicate Device
A Table of Similarities and Differences is attached as Table I.
The two devices utilize the same materials. All materials conform to ASTM standards.
8. Performance Testing
The following testing was carried out for a determination of substantial equivalence:
Surface Finish Analysis Tibial Insert and Tibial Tray Interlock Testing Femoral-Tibial Contact Area Analysis Contact Stress Calculation
606012
2
TABLE I OF EXHIBIT I
TABLE OF SIMILARITIES AND DIFFERENCES
Similarities and Differences Table for Femoral component
| | Min. fixation
peg cross-
sectional area | Undercut on
fixation pegs | Longitudinal
fixation peg
channels | Condylar
geometry |
|--------------------------------------------|-----------------------------------------------|------------------------------|------------------------------------------|----------------------|
| P.F.C. Uni-
system(predicate
device) | Same | No | Yes | Same |
| P.F.C. ∑ Uni-
system | Same | Yes | No | Same |
Similarities and Differences Table for Insert and All UHMWPE Components
| | Assembly
mechanism:
Insert into
tray | Minimum
6 mm
UHMWPE
thickness | M/L topo-
graphy | A/P topo-
graphy | Chamfer |
|------------------------------------------------|-----------------------------------------------|----------------------------------------|---------------------|-------------------------|------------------------------------------------|
| P.F.C. Uni-
system
(predicate
device) | Same | Yes | Same | More
conform-
ing | On
Anterior
portion |
| P.F.C. Σ
Uni-system | Same | Yes | Same | Less
conform-
ing | On
Posterior
and
Anterior
portions |