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

These components are single use only and are intended for implantation with bone cement.

Device Description

The Scorpio® NRG® Knee System comprises a series of femoral and tibial insert components. The subject Scorpio® NRG® X3® inserts are available in cruciate retaining (CR) and posterior stabilized (PS) designs and are used for the replacement of the bearing/articulating surfaces of the proximal tibia. The modification to the subject devices is the sequentially crosslinked and annealed X3® UHMWPE material process.

AI/ML Overview

This document is a 510(k) summary for the Scorpio® NRG® Knee System, which is a total knee joint replacement prosthesis. The document states that the device is substantially equivalent to a previously cleared device. Therefore, no studies are provided to prove the device meets acceptance criteria. Only the indications for use and general device description are provided.

Here's the breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance:

Not available. The document is a 510(k) summary for a substantial equivalence determination, not a clinical trial report. It asserts equivalence to a predicate device rather than presenting new performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available. No new test data is presented in this 510(k) summary. The submission relies on demonstrating equivalence to existing, legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not available. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not available. No test set or adjudication method is described.

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 device is a total knee joint replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not available. No new studies or ground truth establishment are reported in this 510(k) summary.

8. The sample size for the training set:

Not applicable. This device is a physical implant, not a machine learning model.

9. How the ground truth for the training set was established:

Not applicable. This device is a physical implant, not a machine learning model.

Summary of what is available:

Device: Scorpio® NRG® Knee System (Total Knee Joint Replacement Prosthesis)
Approval Type: 510(k) clearance based on substantial equivalence.
Predicate Device: Scorpio NRG Knee System (K042343 and K030978).
Modification: Sequentially crosslinked and annealed X3® UHMWPE material process for the inserts.
Basis for Equivalence: Identical intended use and indications for use, and similar design to the predicate devices.
Indications for Use: (Provided in the original text) Painful, disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis), post-traumatic loss of knee joint configuration, moderate deformities where ligaments can be stabilized, revision of previous procedures. For PS components: ligamentous instability, absent or non-functioning posterior cruciate ligament.
Intended Use: Sterile, single-use device intended for total knee arthroplasty, for implantation with bone cement.

In essence, the document serves as a regulatory submission demonstrating that the modified device is as safe and effective as a previously approved device, thus it does not include new performance studies or data against specific acceptance criteria.

Summary

{0}------------------------------------------------

AUG 1 5 2007

510(k) Summary of Safety and Effectiveness for the

Proprietary Name:	Scorpio® NRG® Knee System
Common Name:	Total Knee Joint Replacement Prosthesis
Classification Name and Reference	888.3560 - Knee joint, patellofemorotibial,polymer/metal/polymer semi-constrained cementedprosthesis
Regulatory Class:	Class II
Device Product Code:	JWH - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
For Information contact:	Patricia Setti-LaPerchRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5938Fax: (201) 831-4938E-Mail: Patricia.LaPerch@stryker.com
Date Summary Prepared:	July 19, 2007

{1}------------------------------------------------

Device Description

Intended Use:

The Scorpio® NRG® Knee System is a sterile, single-use device intended for total knee arthroplasty.

Indications

The Scorpio® NRG® Knee System components are for use in total knee arthroplasty as a result of:

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

These components are single use only and are intended for implantation with bone cement.

Substantial Equivalence:

The subject Scorpio NRG X3 inserts are a modification to the Scorpio NRG System cleared in K042343 [Scorpio NRG Knee System (Cruciate Retaining Components)] and K030978 (Scorpio NRG Knee System Posterior Stabilized). The determination of the substantial equivalence for the Scorpio NRG X3 inserts is based on this line extension's identical intended use and indications for use and similar design to the previously cleared Scorpio NRG Knee System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three wavy lines forming the staff and the snakes, and the text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2007

Howmedica Osteonics Corp. % Ms. Patricia Setti-LaPerch Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K071991

Trade/Device Name: Scorpio® NRG® Knee System 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: July 19, 2007 Received: July 20, 2007

Dear Ms. Setti-LaPerch:

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 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

{3}------------------------------------------------

Page 2 - Ms. Patricia Setti-LaPerch

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara boehme
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): Ko71991

Device Name: Scorpio® NRG® Knee System

Indications

The Scorpio® NRG® Knee System components are for use in total knee arthroplasty as a result of:

. 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 .

These components are single use only and are intended for implantation with bone cement.

Prescription Use

OR Over-the-Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Toubare Bneim

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

510(k) Number K071991

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.