The Columbus REVISION Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity, or dysfunction persist, and for patients suffering from corrective valgus or varus deformity and moderate flexion contracture.

The Columbus REVISION Knee System is designed for use with bone cement.

Device Description

The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Columbus REVISION Knee System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, much of the requested information regarding acceptance criteria, specific studies proving performance against those criteria, sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance, is not applicable or not present in this type of regulatory document.

However, I can extract information related to the performance data provided in the 510(k) submission.

Here's a breakdown of the available information based on your request:

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

Acceptance Criteria (What was tested for)	Reported Device Performance
Endurance testing based on ASTM F 2722-08 for 10 million cycles	Results were found to be similar to the legally marketed Columbus REVISION Knee System (the predicate device).

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

Sample Size: The document does not specify the number of samples (individual devices or components) used for the endurance testing.
Data Provenance: The study was "Customized endurance testing based on ASTM F 2722-08," implying it was a laboratory-based, prospective engineering test. There is no information on country of origin of data in the context of clinical studies as this was a bench test.

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 applicable. This was a mechanical endurance test, not a clinical study requiring expert interpretation or ground truth establishment in that typical sense. The "ground truth" here is the performance of the predicate device under the same test conditions.

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

Not applicable. This was a mechanical endurance test, not a clinical study involving human assessment and 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 knee implant, not an AI or diagnostic imaging device. No MRMC study was performed.

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

Not applicable. This device is a knee implant; it does not involve algorithms or AI. The endurance testing evaluated the device's mechanical integrity on its own.

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

For the endurance test, the "ground truth" or reference point was the performance of the legally marketed Columbus REVISION Knee System (the predicate device) under the same customized ASTM F 2722-08 test conditions. The goal was to show "similarity" rather than an absolute performance benchmark.

8. The sample size for the training set

Not applicable. This device is a medical implant, not an AI algorithm requiring a training set.

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

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

Summary

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K122985
Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS B.

Columbus REVISION Knee System October 24, 2012

Aesculap® Implant Systems, LLC COMPANY: 3773 Corporate Parkway Center Valley, PA 18034

ESTABLISHMENT

REGISTRATION NUMBER: 3005673311

CONTACT:

Julie Tom Wing 610-984-9147 (phone) 610-791-6882 (fax) Julie. TomWing@aesculap.com

DEVICE

TRADE NAME:	REVISION
COMMON NAME:	Columbus REVISION Knee System
DEVICE CLASS:	CLASS II
PRODUCT CODE:	JWH
REGULATION NUMBER:	888.3560
CLASSIFICATION NAME:	Knee Joint PatellofemorotibialPolymer/Metal/Polymer Semi-constrainedCemented Prosthesis

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the modification to Columbus REVISION Knee System remains substantially equivalent to Aesculap Implant Systems Columbus REVISION Knee System originally cleared in 510(K) K083772.

DEVICE DESCRIPTION

OCT 26 2012

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K122985 Page 2 of 2

INDICATIONS FOR USE

The Columbus REVISION Knee System is designed for use with bone cement.

TECHNOLOGICAL CHARACTERISTICS (Compared to the Predicate)

The entire Columbus REVISION Knee System was cleared under K083772. The fundamental scientific technology and materials for the Columbus REVISION Knee System remain the same. The only difference is a design modification of the posterior stabilizing (PS) tibial post of the medium constraint (MC) and high constraint (HC) gliding surfaces (inserts).

PERFORMANCE DATA

Customized endurance testing based on ASTM F 2722-08 was performed on Aesculap Implant Systems Columbus REVISION tibial gliding surfaces, tibial post and fixation screw for 10 million cycles as a result of the risk assessment. The results were found to be similar to the legally marketed Columbus REVISION Knee System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Aesculan Implant System, Incorporated % Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K122985

Trade/Device Name: Columbus REVISION Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 20, 2012 Received: September 26, 2012

Dear Ms. Wing:

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

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Page 2 - Ms. Julie Tom Wing

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

1122985 510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: Columbus REVISION Knee System

Indications for Use:

The Columbus REVISION Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus REVISION Knee System is designed to for use with bone cement.

Prescription Use	X
and/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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122988

002

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.