The Scorpio® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components, Scorpio® CR and ScorpioFlex CR tibial bearing inserts, and Scorpio® patellar components in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray arc outlined below:

Indications

· Painful, disabling joint discasc of the knee resulting from: degenerative arthritis, theumatoid 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.

Device Description

The Scorpio® Low Profile Tibial Tray is a sterile, single-use device that is intended to be used with Scorpio® CR femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The subject Scorpio® Low Profile Tibial Tray is identical in design to the previously cleared Series 7000 Standard Tibial Tray (found substantially equivalent in premarket notification K 910990) with the following exccption: the length of the keel has been decreased to 0.50 inches to allow the implant to be inserted through a smaller incision.

The subject Scorpio® Low Profile Tibial Tray is fabricated from cast cobalt-chromium alloy that conforms to ASTM specification F-75. This tibial tray is offered in eight proportional sizes (sizes 3, 4, 5, 6, 7, 9, 11 and 13) and features the same barb and wire locking mechanism as the previously released Series 7000 Standard tibial tray. The undersurface of the tibial tray has a cast-in waffle surface feature to enhance cement fixation. The waffle pattern interior surface is not an applied coating, but is cast into the cobalt chromium alloy substrate, and consists of a scries of pyramids separated by a distance of 0.53mm, with a pyramid angle of 18°. The keel of the tibial tray utilizes the delta fit keel (swept back normalizations) to provide rotational stability and enhance cement fixation.

AI/ML Overview

Here's an analysis of the provided text regarding the "Scorpio® Low Profile Tibial Tray" and its acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria or detailed results of a performance study for the Scorpio® Low Profile Tibial Tray. Instead, it relies on a demonstration of "substantial equivalence" to a predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance
Structural Integrity: Ability to withstand forces encountered in a knee joint and provide rotational stability.	Demonstrated through Finite Element Analysis (FEA) to support substantial equivalence to the Series 7000 Standard Tibial Tray (K910990). The design, including the waffle surface and delta fit keel, is intended to enhance cement fixation and rotational stability.
Material Compatibility: Use of biocompatible and durable materials.	Fabricated from cast cobalt-chromium alloy conforming to ASTM specification F-75.
Design Equivalence (Primary basis for clearance): Design features (except keel length) are identical or demonstrably equivalent to a legally marketed predicate device.	"The subject Scorpio® Low Profile Tibial Tray is identical in design to the previously cleared Series 7000 Standard Tibial Tray (found substantially equivalent in premarket notification K 910990) with the following exception: the length of the keel has been decreased to 0.50 inches to allow the implant to be inserted through a smaller incision."
Cement Fixation: Ability to achieve secure fixation with cement.	The undersurface has a "cast-in waffle surface feature to enhance cement fixation." The keel also "utilizes the delta fit keel... to provide rotational stability and enhance cement fixation."

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

The document does not describe a "test set" in the context of clinical or performance data. The primary method of demonstrating acceptable performance for this 510(k) submission was through Finite Element Analysis (FEA) and comparison to a predicate device. Therefore, there's no sample size of patients or images, nor data provenance (country of origin, retrospective/prospective). FEA is a computational method.

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

Not applicable. As noted above, there was no "test set" and no ground truth established by human experts in a traditional sense for this device's performance demonstration. FEA relies on engineering principles and models.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or human adjudication was involved in the performance demonstration described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention a MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for an implant like a tibial tray where performance is typically assessed through mechanical testing and equivalence to existing devices.

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

Yes, in a way. The "performance" assessment was primarily the Finite Element Analysis (FEA), which is a standalone computational analysis without human-in-the-loop performance in the context of device function. This FEA determined mechanical equivalence to a predicate.

7. The Type of Ground Truth Used

The "ground truth" for the performance claim (substantial equivalence) was based on:

The established safety and effectiveness of the predicate device (Series 7000 Standard Tibial Tray, K910990).
Engineering principles and validated computational models used in the Finite Element Analysis (FEA) to confirm that the design modification (shorter keel) did not compromise the mechanical performance compared to the predicate.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or AI development for this device. FEA is a simulation method, not a learning algorithm.

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

Not applicable. As there was no training set, there was no ground truth for it to be established.

Summary

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510(k) Premarket Notification

Confidential

ugl / of

Ko 30809

510(k) Summary

Submission Information

Name and Address of Sponsor:

For Information contact:

Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Margaret F. Crowc Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendalc. NJ 07401

Device Identification

Proprietary Name:

Scorpio® Low Profile Tibial Tray

Modular Tibial Tray Common Name:

Classification Name and Reference: Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis - Class II - 21 CFR 888.3560

Proposed Regulatory Class: Class II OR(87) JWH Device Product Code:

Intendcd Use

Indications

· Painful, disabling joint discasc of the knee resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.

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• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Contraindications

· 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 caunot 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 overwcight 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.
· The use of bone augmentations is contraindicated with the Scorpio® Low Profile Tibial Tray

Device Description

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510(k) Premarket Notification

032829
page 3 of 3
Confidential

locking mechanism as the previously released Series 7000 Standard tibial tray. The undersurface of the tibial tray has a cast-in waffle surface feature to enhance cement fixation. The waffle pattern interior surface is not an applied coating, but is cast into the cobalt chromium alloy substrate, and consists of a scries of pyramids separated by a distance of 0.53mm, with a pyramid angle of 18°. The keel of the tibial tray utilizes the delta fit keel (swept back normalizations) to provide rotational stability and enhance cement fixation.

Equivalent products include: Series 7000 Tibial Tray (K910990); Duracon® Cruciform Tibial Tray (K926228); and Interax Modular Tibial Tray (K973121).

Finite clement analysis was presented to support substantial equivalence to a predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEC 1 0 2003

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

Re: K032829 Trade/Device Name: Scorpio® Low Profile Tibial Tray Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: September 10, 2003 Received: September 11, 2003

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.

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

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Page 2 - Ms. Margaret F. Crowe

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 sct 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milliken

Celia 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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510(k) Number (if known): KO32829

Device Name: Scorpio® Low Profile Tibial Tray

The Scorpio® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray are outlined below:

Indications

· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, theumatoid 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.

Contraindications

· 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 collatcral 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.
· The use of bone augmentations is contraindicated with the Scorpio® Low Profile Tibial Tray

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR : ............................................................................................................................................................................ Corological Dovices

Over-The-Counter Use (Per 21 CFR 801.109) (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.