The Osteonics® Scorpio™ Posterior Cruciate Retaining (CR) Total Knee System consists of posterior cruciate retaining total knee replacement femoral components, with corresponding cruciate retaining tibial bearing components, specifically designed to articulate together. These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement when the posterior cruciate ligament is functional.

The Osteonics® Scorpio™ Total Knee CR Femoral Components are compatible for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts and the Osteonics® Scorpio" Total Knee CR All-Polyethylene Tibial Components. The Osteonics® Scorpio" Total Knee CR Tibial Bearing Inserts are intended for use with the legally marketed Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit® Total Knee Tibial Trays.

The Osteonics® Scorpio" Total Knee CR Femoral Components are intended for patello-femoral articulation with the Osteonics® Scorpio™ Total Knee Patellar Components. In addition, the Osteonics® Series 7000 Femoral Bone Augmentation Components are compatible with the Osteonics® Scorpio™ Total Knee CR Femoral Components.

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. .

Device Description

Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining Femoral Components: The Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining (CR) Femoral Components are fabricated from cobalt chromium alloy, available in right and left configurations, with or without two interior fixation lugs, and are available with three different interior surface textures to supplement the cement fixation of the device: basic grit-blasted surface roughness, waffle pattern, and MicroStructured® porous coating. These femoral components achieve primary fixation by interdigitation of the PMMA bone cement with the surface texture and the apposing bone.

Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining All-Polyethylene Tibial Components: The Osteonics® Scorpio" Total Knee Posterior Cruciate Retaining (CR) All-Polyethylene Tibial Components are one-piece total knee replacement tibial components, fabricated from ultra-high molecular weight polyethylene (UHMWPE). The bearing surface of the Osteonics® Scorpio" Total Knee CR All-Polyethylene Tibial Components employ a single M/L radius. A radiographic locator wire is positioned in the distal end of the post and in the inferior/anterior side of the tray. The Osteonics® Scorpio™ Total Knee CR All-Polyethylene Tibial Components are intended for cemented fixation. Primary fixation is to be achieved through interface of the bone cement with the tibial post, which is of the swept back, keeled design.

Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining Tibial Bearing Inserts: The Osteonics® Scorpio™ Total Knee Posterior Cruciate Retaining (CR) Tibial Bearing Inserts are fabricated from ultra-high molecular weight polyethylene (UHMWPE). These tibial bearing inserts are assembled to the appropriate tibial tray intraoperatively via a locking wire mechanism. The bearing surface of the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts employ a single M/L radius, and accommodate the bearing geometry of the Osteonics® Scorpio™ Total Knee CR Femoral Components. The Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts are intended for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Femoral Components. This tibial bearing insert is designed to be assembled with the Osteonics® Series 7000 Total Knee Tibial Trays or the Osteonics® Omnifit® Total Knee Tibial Trays.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to existing predicate devices, not a study proving it meets acceptance criteria through clinical trials or performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a study, sample sizes, expert opinions, or comparative effectiveness with AI.

Here's a breakdown of why the requested information is absent:

Acceptance Criteria and Reported Device Performance: This document describes the device's design, materials, and intended use, and states that "Applicable performance testing demonstrates that the subject components perform at least as well as, if not better than, the predicate commercially available designs." However, it does not specify what those performance criteria were (e.g., wear rate, strength, range of motion, clinical outcomes) nor does it provide a table of reported performance against specific criteria. This type of detailed performance data is typically found in design verification and validation documents, which are usually proprietary and not part of the public 510(k) summary.
Sample Size and Data Provenance: No clinical study or performance data with specific sample sizes is mentioned. The "performance testing" referred to is likely bench testing (mechanical, durability) to ensure the device meets engineering specifications and compares favorably to predicate devices, rather than human subject data.
Number of Experts and Qualifications: Not applicable, as there's no clinical data or image-based diagnostic performance being assessed by experts.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is a knee implant, not an AI software or diagnostic tool that would involve human readers.
Standalone Performance: Not applicable as there's no "algorithm" or AI component. The performance mentioned refers to the mechanical and physical performance of the knee implant itself.
Type of Ground Truth: Not applicable in the context of diagnostic accuracy.
Sample Size for Training Set: Not applicable. This document refers to a physical medical device, not a machine learning model.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory filing for a knee implant, establishing its substantial equivalence to previously marketed devices. It does not include the detailed performance study data you've requested, which is typically generated during the design and development phase and may be summarized in broader terms within a 510(k) submission.

Summary

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FEB 2 7 1998

5974556

510(k) Premarket Notification

Osteonics" Scorpio" Posterior Cruciate Retaining Total Knee System

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SCORPIO™ POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Submission Information Name and Address of the Sponsor of the 510(k) Submission:

Date Summary Prepared:

Donna S. Wilson Regulatory Affairs Specialist

Osteonics Corporation

Allendale, NJ 07401-1677

59 Route 17

201-825-4900

December 4, 1997

Device Identification Proprietary Name:

Contact Person:

Common Name:

Classification Name and Reference:

Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System

Knee Prosthesis

Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis 21 CFR §888.3560

Predicate Device Identification

The Osteonics® Scorpio™ Total Knee CR Femoral Components are substantially equivalent to both the Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Femoral Components, and the Osteonics® Series 7000 Total Knee Femoral Components. The Osteonics® Scorpio" Total Knee CR All-Polyethylene Tibial Components are substantially equivalent to the Osteonics® Series 7000 Total Knee All-Polyethylene Tibial Components. The Osteonics® Scorpio" Total Knee CR Tibial Bearing Inserts are substantially equivalent to the Osteonics® Tibial Bearing Inserts.

Device Description

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Osteonics" Scorpio" Posterior Cruciate Retaining Total Knee System

MicroStructured® porous coating. These femoral components achieve primary fixation by interdigitation of the PMMA bone cement with the surface texture and the apposing bone.

Intended Use

These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement in conjunction with an Osteonics® Scorpio™ Patellar Component, when the posterior cruciate ligament is functional. The indications for use of the Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System are as follows:

. 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.
t Revision of previous unsuccessful knee replacement or other procedure.

Statement of Technological Comparison

The Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System components share the same materials, intended use, and basic design features of their respective predicate devices. Applicable performance testing demonstrates that the subject components perform at least as well as, if not better than, the predicate commercially available designs.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image in the center appears to be a representation of the human form, possibly symbolizing health and well-being. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" clearly visible.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

K974556 Re: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System Regulatory Class: II Product Code: JWH December 4, 1997 Dated: December 5, 1997 Received:

Dear Ms. Wilson:

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 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

This device may not be labeled or promoted for non-1. cemented use. . . . . . . . . . . .
All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the device is intended for cemented use only.

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Page 2 - Ms. Donna S. Wilson

Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Druq Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. ਮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Ms. Donna S. Wilson

obtained from the Division of Small Manufacturers Assistance obtained from the bivision of omail handr (301) 443-6597 or at at fes corr rrec namble (o://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 974556

Device Name: Osteonics® Scorpio™ Posterior Cruciate Retaining Total Knee System

Indications For Use:

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. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) Intional Format 1-2-96) 974556 510(k) Number

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.