(70 days)
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No
The summary describes a prosthetic knee joint and its components, focusing on materials, intended use, and mechanical performance testing. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is a prosthetic knee system intended to replace a damaged natural knee joint, which falls under the definition of a therapeutic device designed to treat a medical condition (severe pain and disability due to permanent structural damage).
No
The device description clearly states it is a "prosthetic device intended to replace the natural knee joint," which is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like UHMWPE, Titanium, and Co-Cr-Mo alloy, indicating it is a hardware-based prosthetic device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthetic knee system for patients suffering from severe pain and disability due to knee joint damage. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the components of a prosthetic knee joint (femoral component, tibial inserts, patellae, etc.) made of materials like UHMWPE, Titanium, and Co-Cr-Mo alloy. These are materials used for implants, not for analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
This device is a Class III medical device (based on the description of it being a prosthetic implant) intended for surgical implantation to replace a damaged knee joint.
N/A
Intended Use / Indications for Use
The P.F.C.® ∑ Cruciate Retaining Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Product codes
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Device Description
The P.F.C.® ∑ Cruciate Retaining Knee System (Size 1.5) consists of:
- Size 1.5 asymmetrical Femoral component, both porous & non-porous coated:
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- Size 1.5 Tibial inserts;
- Size 1.5 All-Polyethylene Tibiae (APT);
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- Size 1.5 Tibial trays;
- Size 32mm Oval dome patellae, three and single peg.
The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE. Titanium and Co-Cr-Mo alloy.
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
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted for a determination of substantial equivalence:
Constraint Testing
Contact Areas between all Interfacing Components
Surface Characteristics of Articulating Surfaces Modified Surface Data Form Testing Tibial Insert/Tibial Tray Interlock Testing Lateral Stability of Patellofemoral Joint Fixation Testing of Patella Component (Tensile & Shear) Fatigue Strength of the Tibial Component
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
P.F.C. Cruciate Retaining Knee System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K96/685
510(k) Summary April 26, 1996
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person: John Ferros Phone: 508.880.8287
Name of Device
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87. Common Name: Semi-constrained total knee prosthesis.
Trade Name/Proprietary Name: P.F.C.® ∑ Cruciate Retaining Knee System (Size 1.5)
Performance Standards: No performance standards have been developed for this device.
Predicate Device
P.F.C. Cruciate Retaining Knee System
Description of Device
The P.F.C.® ∑ Cruciate Retaining Knee System (Size 1.5) consists of:
- Size 1.5 asymmetrical Femoral component, both porous & non-porous coated:
-
- Size 1.5 Tibial inserts;
- Size 1.5 All-Polyethylene Tibiae (APT);
-
- Size 1.5 Tibial trays;
- Size 32mm Oval dome patellae, three and single peg.
The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE. Titanium and Co-Cr-Mo alloy.
Intended Use
The P.F.C.® ∑ Cruciate Retaining Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Technological Characteristics Compared to Predicate Device
All technical characteristics are identical to the Predicate Device. The P.F.C.® Cruciate Retaining Knee System (Size 1.5) is identical to the Predicate device except we are introducing smaller sized components.
Performance Tests
The following tests were conducted for a determination of substantial equivalence:
Constraint Testing
Contact Areas between all Interfacing Components
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Surface Characteristics of Articulating Surfaces Modified Surface Data Form Testing Tibial Insert/Tibial Tray Interlock Testing Lateral Stability of Patellofemoral Joint Fixation Testing of Patella Component (Tensile & Shear) Fatigue Strength of the Tibial Component
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