The Columbus Total 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 Knee is designed for use with bone cement.

The EnduRo 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.

Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

The EnduRo Knee System is intended for cemented use only.

Device Description

The Columbus Total Knee System AS includes both "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts and patellae. The tibial hemi-spacers (wedges) are the same design as the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). All components manufactured from CoCrMo are coated with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220).

The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" (insert) and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (Zirconium nitride) coating. All components are sterile and for single use only.

AI/ML Overview

This is a 510(k) premarket notification for two medical devices: the Columbus Total Knee System AS and the EnduRo Knee System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study of diagnostic or predictive performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and reader studies is not applicable or cannot be extracted from the provided text.

Here is an attempt to address the points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated as such in a quantitative sense)	Reported Device Performance (Summary of results)
Columbus Total Knee System AS:
Substantial equivalence to predicate devices (K071220 and K053390)	Determined to be substantially equivalent based on design verification and risk assessment. The only differences are a line extension (narrow CR and PS femurs) and the introduction of AS coated tibial hemi-spacers with a smaller size, with the AS coating previously cleared.
Compliance with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"	All required testing was performed where applicable.
EnduRo Knee System:
Substantial equivalence to predicate devices (K101815)	Determined to be substantially equivalent. The only difference is a design modification to the locking nut.
Compliance with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"	All required testing was performed where applicable.
Resistance against loosening of the screw connection of the tibia component and the tibia locking ring	Mechanical testing performed for 5 million cycles. Results were found to be substantially equivalent to the predicate.

Explanation: The document does not provide specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific mechanical thresholds with defined failure rates) that a device must meet. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices and fulfilling general regulatory requirements for orthopedic devices. The "reported device performance" are statements summarizing the outcome of these evaluations, primarily asserting equivalence.

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

Not Applicable / Not Provided: The submission is for orthopedic implants (total knee systems), not a diagnostic or predictive AI device. The "testing" mentioned refers to design verification and mechanical testing, not a clinical trial with a "test set" of patient data. Therefore, concepts like country of origin for a data test set, or whether data was retrospective or prospective, do not apply here.

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

Not Applicable / Not Provided: As these are physical medical devices (implants) and not AI/diagnostic tools, there is no "ground truth" in the context of disease detection or prediction established by experts for a test set. The evaluation is focused on engineering and material equivalence.

4. Adjudication method for the test set

Not Applicable / Not Provided: There is no "test set" of data or images requiring adjudication by experts in this context.

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 / No: This is not an AI-assisted diagnostic device; it is a knee implant. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.

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

Not Applicable / No: This is not an algorithm or software device.

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

Not Applicable / Not Explicitly Stated as "Ground Truth" as defined for diagnostic AI: For these devices, "ground truth" would relate to the established mechanical and biological performance characteristics of the predicate devices, against which the new devices are compared. This involves material properties, dimensional analysis, and biomechanical testing. The reference standard for these characteristics is implicitly defined by existing regulatory standards, predicate device data, and engineering specifications, rather than clinical "ground truth" from pathology or outcomes data for diagnosis.

8. The sample size for the training set

Not Applicable / Not Provided: These devices are not AI models that require a "training set."

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

Not Applicable / Not Provided: These devices are not AI models that require a "training set."

Summary

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K120955

510(k) Premarket Notification

Columbus Total Knee System AS

Page 1 of 2

DEC 1 7 2002 |

510(k) SUMMARY (as required by 21 CFR 807.92)

Columbus Total Knee System AS December 17, 2012

COMPANY:

Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley. PA 18034 Establishment Registration Number: 3005673311

CONTACT:

Julie Tom Wing 800-234-9179 (phone) 610-791-6882 (fax) julie tomwing@aesculap.com (email)

TRADE NAME:	Columbus Total Knee System AS
COMMON NAME:	Total Knee System
CLASSIFICATION NAME:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
REGULATION NUMBER:	888.3560

PRODUCT CODE: JWH

SUBSTANTIAL EQUIVALENCE

The Columbus Total Knee System Alternate Surface (AS) is substantially equivalent to Aesculap's Columbus Total Knee System (K071220) and the previously cleared Columbus Total Knee System (CRA/PSA) (K053390).

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The Columbus Total 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 valous or varus deformity and moderate flexion contracture.

The Columbus Knee is designed for use with bone cement.

TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The base materials used for the new Aseculap implants are the same as that used to manufacture the predicate Aesculap devices. The only differences are a line extension introducing narrow CR and PS femurs and an introduction of AS coated tibial hemispacers including a smaller size (0/0+) hemi-spacer.

The Columbus narrow femurs are a dimensional modification that is available in right and left configurations in sizes that fall within the size range of femoral components previously cleared in Columbus AS Total Knee System (AS) (K071220).

The AS coated tibial hemi-spacers are a design change to the previously approved hemispacers cleared in K053390. The smaller size (0/0+) hemispacer is designed to mate with the same standard size or respective plus-size trays (i.e. TO wedge/T0+ tibial tray). The AS coating was cleared previously in K071220.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable.

Design verification of the Columbus Total Knee System AS was performed as a result of the risk assessment which were determined to be substantially equivalent to the predicates.

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510(k) Premarket Notification

EnduRo Knee System

Page 1 of 2

510(k) SUMMARY (as required by 21 CFR 807.92)

EnduRo Knee System December 17, 2012

COMPANY:

Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

CONTACT:

Julie Tom Wing 800-234-9179 (phone) 610-791-6882 (fax) julie tomwing@aesculap.com (email)

TRADE NAME: EnduRo Knee System

COMMON NAME: Total Knee System

CLASSIFICATION NAME: Prosthesis. Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

REGULATION NUMBER: 888.3510

PRODUCT CODE: KRO

SUBSTANTIAL EQUIVALENCE

The EnduRo Knee System is substantially equivalent to previously cleared, Aesculap Implant Systems EnduRo Knee System (K101815).

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The EnduRo Knee System is indicated for use in reconstruction of the diseased knee ioint 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 EnduRo Knee System is intended for cemented use only.

TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The base materials used for the new Aseculap implants are the same as that used to manufacture the predicate Aesculap devices. The only difference is a design modification to the locking nut.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where " applicable.

Mechanical testing to evaluate the resistance against loosening of the screw connection of the tibia component and the tibia locking ring of Aesculap EnduRo Knee System was performed for 5 million cycles. Results were found to be substantially equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.

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

Letter dated: December 17, 2012

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

Re: K120955

Trade/Device Name: COLUMBUS Total Knee System AS and EnduRo Knee System Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Codes: JWH, KRO Dated: December 13, 2012 Received: December 14, 2012

Dear Ms. Tom Wing:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

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Page 2 -- Ms. Julie Tom Wing

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Columbus Total Knee System AS

Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number:_

Device Name: Columbus Total Knee System AS

Indications for Use:

The Columbus Knee is designed for use with bone cement.

× and/or Over-the-Counter Use Prescription Use (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINEACONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
K120955

510(k) Number .

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Page 1 of 1

A.

510(k) Number:_

Device Name: EnduRo Knee System

The EnduRo Knee System is intended for cemented use only.

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)

and Restorative Devices

510(k) Number	K120955
---------------	---------

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.