Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.

Device Description

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Disposable Knee Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.

AI/ML Overview

This document is a 510(k) premarket notification for "Disposable Knee Instruments" by Smith & Nephew, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

This submission does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. This is typical for submissions of this nature, especially for surgical instruments, where equivalence is primarily established through design, material, and intended use comparison rather than a clinical performance study with statistical endpoints.

Here's a breakdown of the requested information based on the provided document, with notes where information is not applicable or present:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Demonstrated through ISO 10993 testing or use of previously cleared predicate raw materials.
Dimensions	Similar or equivalent to predicate devices.
Surgical Procedures	Share identical surgical procedures with predicate devices.
Sterilization Procedures	Utilize the same sterilization procedures as predicate devices.
Nature of Body Contact	Similar to predicate devices.
Intended Use	To assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems, as per their cleared indications for use for Total Knee Replacement. This matches the predicate devices' intended use.

Explanation: The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices across several key attributes. The "reported device performance" refers to the claim of similarity or identity to the predicate devices for these attributes. There are no quantitative performance metrics (e.g., accuracy, precision) stated that typically define acceptance criteria for diagnostic devices or more active therapeutic devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This submission is for surgical instruments, and substantial equivalence is demonstrated through design and functional comparison, not through a "test set" of patient data or clinical outcomes.
Data Provenance: Not applicable. No clinical data or patient data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "test set" of medical cases requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There is no "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 device is a set of disposable surgical instruments, not an AI or imaging device.

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

Not applicable. This device is a set of disposable surgical instruments, not an algorithm.

7. The type of ground truth used

Not applicable. No ground truth in the context of clinical outcomes or diagnostic accuracy is used. The "ground truth" for this submission is established through engineering and material standards (e.g., ISO 10993 for biocompatibility) and comparison to existing, cleared devices.

8. The sample size for the training set

Not applicable. This device is a set of disposable surgical instruments, not a machine learning model.

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

Not applicable. This device is a set of disposable surgical instruments, not a machine learning model.

Summary

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Sto (K) Summary of Safety and Effectiveness Disposable Knee Instruments Smith & Nephew, Inc.

Contact Person and Address Martin Ostmann Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 Tel: (901) 399-1809 FAX: (901) 566-7080

Date of Summary: May 3, 2013

MAY 0 3 2013

Name of Device: Disposable Knee Instruments Common Name: Orthopaedic Surgical Instrumentation Device Classification Name and Reference:

CFR Number	Description	Classification
888.3560	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis	II
888.3565	Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis	II

Device Class: Class II

Panel Code: Orthopaedics/87 Product Code: JWH, MBH

Predicate Devices:

Smith & Nephew Inc. Compatible Knee Systems

Description	510(k)	Clearance Date
LEGION PRIMARY KNEE SYSTEM	K093746	4/14/10
GENESIS II TOTAL KNEE SYSTEM	K951987	8/22/1995
GENESIS II P/S HIGH FLEXION KNEE INSERT	K032295	8/21/03
GENESIS II DEEP FLEXION C/R ARTICULAR INSERT	K041825	3/11/05
TOTAL KNEE SYSTEM INSTRUMENTATION	K121393	8/7/12

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Summary of Safety and Effectiveness Disposable Knee Instruments Smith & Nephew, Inc.

Device Description

Intended Use / Indications for Use

Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems including Legion and Genesis II Knee Systems and their cleared Indications for Use.

Substantial Equivalence Information

The Disposable Knee Instruments are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments:

Have demonstrated biocompatibility through ISO 10993 testing or through use of previously cleared predicate raw materials;
. Have similar or equivalent dimensions;
Share identical surgical procedures;
Utilize the same sterilization procedures; and ●
Have similar nature of body contact .

The Smith and Nephew Disposable Knee Instruments are similar in design and function to the existing Smith and Nephew Total Knee Instrumentation cleared via K121393.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Smith & Nephew, Incorporated % Mr. Martin Ostmann Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

Re: K123159

Trade/Device Name: Disposable Knee Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: April 12, 2013 Received: April 15, 2013

Dear Mr. Ostmann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Martin Ostmann

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

· Sincerely yours.

Erin Meith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123159

Device Name: Disposable Knee Instruments Indications for Use:

Prescription Use	X	AND/OR
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

ter Use

nart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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.