The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty.

Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized Components:

Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.

Device Description

The Scorpio CR and PS Femoral Components with Titanium Plasma Spray Coating, and the Scorpio® Tibial Tray with Titanium Plasma Spray Coating, are substantially equivalent to the predicate Cobalt Chromium alloy (CoCr) MicroStructured® Scorpio® CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured® standard tibial trays of the Osteonics® Series 7000 Total Knee System (#K910990) in all material and design aspects. The following reflect the new characteristics of the subject components:

The interior surfaces of the subject Scorpio® CR and PS femoral components with Titanium Plasma Spray Coating receive a titanium plasma spray coating instead of the MicroStructured® porous coating. All other design features of the femoral components are identical to the predicate devices.
For the Scorpio Tibial Tray with Titanium Plasma Spray Coating, the inferior surface of the tibial tray receives a titanium plasma spray coating (as opposed to a MicroStructured® porous coating), and the keel of the tray receives a thin titanium plasma spray coating. The plate of the subject tibial tray is 0.75mm thicker than that of the predicate tibial tray, and has been filled in with cobalt chromium alloy. Also, the screw hole configuration on the titanium plasma sprayed trays has been modified to allow greater angulation of the screws.

AI/ML Overview

This document is a 510(k) summary for the Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating. It does not describe a study involving an AI/ML device, but rather a medical device (knee implants). Therefore, many of the requested categories for AI/ML studies are not applicable.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission is for demonstrating substantial equivalence to predicate devices, not for meeting specific performance acceptance criteria for a novel device. The "acceptance criteria" here implicitly refer to the FDA's requirements for demonstrating substantial equivalence.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as claimed by manufacturer)
Material Equivalence: The new device's materials are comparable to predicate devices.	The plasma-sprayed commercially pure ("CP") Titanium coating is identical to the coating used on predicate Howmedica Osteonics® femoral stems. The combination of a CoCr substrate and a plasma sprayed CP Titanium coating on a knee component is substantially equivalent to the CoCr substrate/Titanium alloy coating metal combination employed by the legally marketed predicate MCK® Total Knee System manufactured by Biomet, Inc.
Design Equivalence: The new device's design is comparable to predicate devices.	The interior surfaces of the subject Scorpio® CR and PS femoral components with Titanium Plasma Spray Coating receive a titanium plasma spray coating instead of the MicroStructured® porous coating. All other design features of the femoral components are identical to the predicate devices. For the Scorpio® Tibial Tray with Titanium Plasma Spray Coating, the inferior surface receives a titanium plasma spray coating, the keel receives a thin titanium plasma spray coating. The plate of the subject tibial tray is 0.75mm thicker than that of the predicate tibial tray, and has been filled in with cobalt chromium alloy. The screw hole configuration was modified. These changes maintain substantial equivalence in design given the overall context of knee implants.
Intended Use Equivalence: The new device has the same intended use as predicate devices.	The intended use for the new Scorpio® components is for cemented fixation only, with Osteonics tibial inserts and patellar components in total knee arthroplasty, which is consistent with the predicate devices. Specific indications and contraindications are provided, matching established uses for similar knee implants.
Safety and Effectiveness Equivalence: The new device is as safe and effective as predicate devices.	"Testing was provided to support the claim of substantial equivalence." (Specific test results are not detailed in this summary, but would have been part of the full 510(k) submission). The FDA concurrence letter confirms their determination of substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes a 510(k) submission for a medical device (knee implants), not an AI/ML study. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here. The "testing" referred to would typically involve mechanical, material, and potentially biological compatibility testing, not data analysis on a clinical dataset in the AI/ML sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not an AI/ML study involving "ground truth" establishment from expert consensus. The "ground truth" for a medical device like a knee implant is established through rigorous engineering standards, material science, and clinical performance over time, not expert labeling of data.

4. Adjudication Method (2+1, 3+1, none) for the Test Set

Not applicable. This is not an AI/ML study.

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 medical device submission, not an AI/ML comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the AI/ML sense. For this type of device, "ground truth" would be related to:

Material properties: Established through laboratory testing (e.g., tensile strength, fatigue life, biocompatibility standards).
Mechanical performance: Established through in-vitro biomechanical testing (e.g., wear testing, fixation strength, range of motion).
Clinical outcomes (for predicate devices): Long-term clinical data on the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML study.

Summary of the Document's Purpose:

The provided document is a 510(k) summary for new knee implant components. The primary goal of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This means the device has the same intended use and either has the same technological characteristics as the predicate device or has different technological characteristics that do not raise different questions of safety and effectiveness and demonstrate that the device is as safe and effective as the legally marketed device. The document explicitly states that the new components are "substantially equivalent" to existing predicate devices in terms of materials, design (with minor, justified modifications), and intended use.

Summary

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NOV 1 3 2002

510(K) SUMMARY

Scorpio® CR and PS Femoral Components and Scorpio® Tibial Tray with Titanium Plasma Sprayed Coating

The interior surfaces of the subject Scorpio® CR and PS femoral components with 미 Titanium Plasma Spray Coating receive a titanium plasma spray coating instead of the MicroStructured® porous coating. All other design features of the femoral components are identical to the predicate devices.
For the Scorpio Tibial Tray with Titanium Plasma Spray Coating, the inferior 미 surface of the tibial tray receives a titanium plasma spray coating (as opposed to a MicroStructured® porous coating), and the keel of the tray receives a thin titanium plasma spray coating. The plate of the subject tibial tray is 0.75mm thicker than that of the predicate tibial tray, and has been filled in with cobalt chromium alloy. Also, the screw hole configuration on the titanium plasma sprayed trays has been modified to allow greater angulation of the screws.

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K020703 p 2-1

The plasma-sprayed commercially pure ("CP") Titanium coating is identical to the coating used on the predicate Howmedica Osteonics® femoral stems. The combination of a CoCr substrate and a plasma sprayed CP Titanium coating on a knee component is substantially equivalent to the CoCr substrate/Titanium alloy coating metal combination employed by the legally marketed predicate MCK® Total Knee System manufactured by Biomet, Inc.

Intended Use

The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for singleuse, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty. These Scorpio® femoral components and the tibial tray are similar in design to the predicate Scorpio® CR and PS femoral components and Osteonics® Series 7000 tibial tray, with the exception the titanium plasma spray coating.

The following are the specific indications/contraindications for the Scorpio® CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio® Tibial Tray with Titanium Plasma Sprayed Coating:

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510(k) Summary Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating

Indications:

. Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
. Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized Components:

Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
. Absent or non-functioning posterior cruciate ligament.

Contraindications:

The contraindications for the subject devices include:

. Any active or suspected latent infection in or about the knee joint.
. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
Bone stock compromised by disease, infection or prior implantation which cannot ● provide adequate support and/or fixation to the prosthesis.
. Skeletal immaturity

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510(k) Summary Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating

Severe instability of the knee joint secondary to the absence of collateral ligament . integrity and function.
Obesity. An overweight or obese patient can produce loads on the prosthesis . which can lead to failure of the fixation of the device or to failure of the device itself.

Testing was provided to support the claim of substantial equivalence.

For further information contact: Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401 (201) 934-4359 (Telephone) (201) 760-8435 (Fax)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that appears to be three abstract shapes stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Regulatory Affairs Consultant Stryker® Howmedica Osteonics 59 Route 17 South Allendale, New Jersey 07401

Re: K020703

Trade/Device Name: Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating Regulation Number: 21 CFR §888.3560 Regulation Name: Knee joint, patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH Dated: August 22, 2002 Received: August 23, 2002

Dear Ms. Crowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Margaret F. Crowe -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

L. Mark A. Mellmann

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): KO20203

Device Name: Scorpio® CR and PS Femoral Components and Scorpio® Tibial Tray with Titanium Plasma Spray Coating

Indications for Use:

The following are the specific indications/contraindications for the Scorpio® CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio Tibial Tray with Titanium Plasma Sprayed Coating:

Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
. Post-traumatic loss of knee joint configuration and function.
. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized Components:

Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.

Contraindications:

The contraindications for the subject devices include:

Any active or suspected latent infection in or about the knee joint.
Any mental or neuromuscular disorder which would create an unacceptable risk
of prosthesis instability, prosthesis fixation failure or complications in postoperative care.

Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.

Skeletal immaturity
Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) ·

・

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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(Division Sign
Dision of Curl Rustorative
and Neurological Devices

510(k) Number K020703

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.