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.

Device Description

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.

AI/ML Overview

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."

Summary

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JUN 1 9 2001

510(k) Summary PFC Sigma Lugged Tibial Tray

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907

B. Device Information:

Proprietary Name:	PFC Sigma Lugged Tibial Tray
Common Name:	Tibial Tray
Classification Name:	Knee Joint Patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis
Regulatory Class:	Class II, per 21 §CFR 888.3560
Product Code:	87 JWH

C. Indications for Use:

Caution: This knee prosthesis component is intended for cemented use only.

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510(k) Summary (Continued) PFC Sigma Lugged Tibial Tray

D. Device Description:

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.

E. Substantial Equivalence:

The PFC Sigma Lugged Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Trick Modular Knee Tibial Tray -Porous (K931054) and the P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106).

The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards, e.g. ASTM F-1580, and ASTM F1044.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JUN 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson, RAC Group Leader, Regulatory Submissions Depuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K003026

Trade Name: PFC Sigma Lugged Tibial Tray Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: March 23, 2001 Received: March 26, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Janet G. Johnson, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

lelluror

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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510(k) Number (if known) Device Name

KOD 3026 PFC Sigma Lugged Tibial Tray

Indications for Use

Caution: This knee prosthesis component is intended for cemented use only.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr.

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KOO 3026 510(k) Number _

Prescription Use X (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.