(264 days)
The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.
Caution: This knee prosthesis component is intended for cemented use only.
The PFC Sigma Lugged Tibial Tray is designed with four angled pegs to provide firm fixation and anti-rotational properties while preserving bone stock. It is manufactured from titanium alloy (Ti-6A1-4V) and the distal surface is coated with commercially pure titanium porous coating to enhance cement fixation. If additional fixation is required, the tibial tray is designed with one screw hole to accept a bone screw.
The PFC Sigma Lugged Tibial Tray is designed for use with both P.F.C. Modular and P.F.C. Sigma tibial inserts, including curved, posterior lipped and stabilized.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the PFC Sigma Lugged Tibial Tray:
Summary of Acceptance Criteria and Study Information:
This 510(k) submission for the PFC Sigma Lugged Tibial Tray does not describe acceptance criteria or a study proving the device meets those criteria in the context of device performance as one might expect for a novel or software-driven medical device.
Instead, this document is a premarket notification where the manufacturer, DePuy Orthopaedics, Inc., is seeking to demonstrate substantial equivalence to already legally marketed predicate devices. The "study" here is primarily a comparison based on design, materials, and intended use, rather than a clinical performance study with predefined acceptance metrics.
Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the document is a regulatory submission for substantial equivalence for a physical implant, not a study evaluating performance against specific numeric criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (If Applicable) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall) | Demonstrated equivalence to predicate devices (Trick Modular Knee Tibial Tray -Porous, K931054, and P.F.C. Sigma Porous Modular Keel Tibial Tray, K991106) in terms of: | The PFC Sigma Lugged Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the cited predicate devices. FDA concurred with this determination (K003026). |
| Design | Not explicitly stated as numeric criteria, but implied to be comparable to predicates. | Designed with four angled pegs for firm fixation and anti-rotational properties while preserving bone stock. Designed with one screw hole for additional fixation. Design is compatible with P.F.C. Modular and P.F.C. Sigma tibial inserts (curved, posterior lipped, stabilized). This design is considered substantially equivalent to the predicate devices. |
| Material | Not explicitly stated as numeric criteria, but implied to be comparable to predicates. | Manufactured from titanium alloy (Ti-6A1-4V). Distal surface coated with commercially pure titanium porous coating. These materials are considered substantially equivalent to the predicate devices. |
| Biocompatibility/Safety | Not explicitly stated as numeric criteria, but implied through substantial equivalence and conformance to standards. | Conformance with voluntary performance standards, e.g., ASTM F-1580 (Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Forgings for Surgical Implants) and ASTM F1044 (Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings). This implies the materials and design meet recognized safety standards. |
| Mechanical Performance/Fixation | Not explicitly stated as numeric criteria, but implied through substantial equivalence and conformance to standards. | Conformance with voluntary performance standards, e.g., ASTM F-1580 and ASTM F1044. The design's "four angled pegs to provide firm fixation and anti-rotational properties" addresses key mechanical aspects. These standards and design features are deemed adequate based on the predicate devices. |
| Indications for Use | Match or are comparable to predicate devices. | The indications for use are provided and are considered to be substantially equivalent to the predicate devices to allow market clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on a comparison to predicate devices and conformance to voluntary standards, not a specific "test set" of patient data or clinical outcomes for this new device.
- Data Provenance: Not applicable for a "test set" as understood for a performance study. The data provenance relevant here is the existence and regulatory clearance of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in the context of clinical outcomes or diagnostic accuracy is not relevant for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. There was no specific "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- Not applicable. This is a physical implant, not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical implant.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission: The "ground truth" is largely established by the regulatory acceptance and safe marketing history of the predicate devices (Trick Modular Knee Tibial Tray -Porous (K931054) and P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106)). The conformance to voluntary performance standards (ASTM F-1580, ASTM F1044) also acts as a form of reference to acceptable material and mechanical properties.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device and submission type.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set."
§ 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.