Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is intended for cemented use only.

Device Description

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments.
The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

AI/ML Overview

The provided 510(k) summary for the Renovis Surgical Technologies, LLC A200 Knee System (K120038) does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.

This document is a premarket notification for a medical device (a knee prosthesis system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not involve a clinical study with a test set, ground truth, or expert adjudication in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, the "proof" is based on non-clinical testing data and a comparison of technological characteristics to existing devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, meaning it is as safe and effective.
Reported Device Performance: The document lists several types of non-clinical tests performed, such as:
- Component testing (tibial tray fatigue, contact area, contact stress, constraint, and tibial insert-tray interlock strength)
- UHMWPE material characterization (density, swell ratio, oxidation index, trans-vinylene index, melting point, crystallinity, vitamin E content, free-radical content, assessment of consolidation, and analysis of extraction residues)
- UHMWPE mechanical testing (Izod impact resistance, tensile properties, compressive properties, small punch testing, fatigue crack propagation, and environmental stress cracking)
- Force-control wear testing according to ISO 14243-1 and ISO 14243-2.
The performance is described qualitatively as "demonstrated the A200 Knee System to be substantially equivalent" or "was substantially equivalent to the predicate devices." No specific numerical results or thresholds are given.

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

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of a clinical trial used to evaluate an AI algorithm. The device is a physical implant. The "testing" refers to laboratory-based, non-clinical mechanical and material characterization.

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. There is no "ground truth" established by experts in this context. The "proof" is based on engineering and material science standards and comparisons to accepted devices.

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

Not applicable. There is no adjudication in this type of submission.

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 physical knee implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.

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

Not applicable. This is not an algorithm or software.

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

Not applicable in the typical sense. The "ground truth" for a knee implant's safety and effectiveness in a 510(k) context is established by adherence to recognized standards (e.g., ASTM, ISO), mechanical properties, material biocompatibility, and demonstrated performance (e.g., wear rate, fatigue strength) compared to devices already on the market that have a known safe and effective history.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

Summary of what the document does provide regarding "proof" of meeting requirements:

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical testing data that demonstrates the A200 Knee System is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria (Implicit): The device must be as safe and effective as the predicate devices, and any differences in technological characteristics must not raise new issues of safety or efficacy.
Study Design/Methodology: Non-clinical (benchtop) testing, material characterization, and comparison to predicate devices.
Key Findings: The document states that:
- Constraint, contact area, and contact stress testing demonstrated substantial equivalence to predicate devices K923277, K892800, K932837, and K935080.
- Wear rate testing of the UHMWPE with vitamin E was substantially equivalent to predicate devices K103223 and K100048.
- Overall, the device "has the same intended use," "uses the same operating principles," "incorporates the same basic designs," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices.

In essence, for a physical implant like the A200 Knee System, "meeting acceptance criteria" in a 510(k) means successfully proving substantial equivalence through a battery of engineering tests and a detailed comparison to existing, cleared devices.

Summary

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510(k) Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Summary Renovis Surgical Technologies, LLC A200 Knee System K120038

January 29, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name: Renovis Surgical Technologies, LLC 1901 W. Lugonia Avenue, Suite 340 Redlands, CA 92374 +1 (909) 557-2360 Telephone: Fax: +1 (909) 307-8571 Official Contact: Anthony DeBenedictis Vice President of Quality Assurance Representative/Consultant: Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236

Email:

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:Common Name:Classification Names:	A200 Knee SystemTotal Knee Prosthesis SystemProsthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer/metal/polymer;Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer + additive/metal/polymer + additive
Classification Regulations:	21 CFR 888.3560, Class II
Product Code:	JWH, OIY
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

kthomas@paxmed.com flarson@paxmed.com

FEB 1 4 2013

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INTENDED USE

The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for cemented use only.

DEVICE DESCRIPTION

The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

EQUIVALENCE TO MARKETED DEVICES

Renovis Surgical Technologies, LLC, submits the following information in this Premarket Notification to demonstrate that for the purposes of FDA's regulation of medical devices, the A200 Knee System is substantially equivalent in indications and design principles to the following legally marketed predicate devices, each of which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:

DePuy Orthopaedics, Inc., DePuy Sigma Knee Femoral Adapter, K060515;

Encore Medical, L.P., Highly Cross-Linked Vitamin E UHMWPE Tibial Insert, K103223;

Biomet Manufacturing Corp., E1™ Tibial Bearings, K100048;

Encore Orthopedics, Inc., Foundation Knee System, K923277;

Zimmer, Inc., MG II Porous Total Knee System, K892800;

U.S. Medical Products, Inc., Consensus Knee System - Primary Knee, K932837; and

Hospital for Special Surgery, Insall-Burstein II, K935080.

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510(k) Summary K120038

The A200 Knee System and the predicate device K060515 are patellofemorotibial knee prosthesis systems, intended for cemented total knee arthroplasty, having the same intended use and similar indications for use.

The A200 Knee System and the predicate device K060515 are made of the same materials, Co-Cr-Mo alloy (femoral components and tibial tray components) and highly crosslinked UHMWPE (tibial insert components and patellar components), and all are provided sterilized by gamma irradiation or ethylene oxide.

The subject and predicate device K060515 have femoral components designed specifically for the right and left knees, in cruciate retaining (CR) designs, and provided in a range of sizes. Similarly, the subject device and the predicate device K060515 also include tibial trays that incorporate a similar stabilizing keel design, and both devices also include UHMWPE tibial inserts in CR designs for use with the corresponding femoral components.

The A200 Knee System and the predicate device K060515 components are similar in overall shape and design. The subject device and the predicate devices encompass a similar range of physical dimensions, including the AP and ML dimensions of the femoral and tibial tray components, the thickness of the tibial insert components, and the thickness and diameter of the patellar components. Constraint, contact area, and contact stress testing demonstrated the A200 Knee System to be substantially equivalent to K923277, K892800, K932837, and K935080.

The A200 Knee System and the predicate devices K103223 and K100048 include tibial inserts manufactured from UHMWPE containing alpha-tocopherol (vitamin E). Performance testing demonstrated that the wear rate of the A200 Knee System UHMWPE with vitamin E was substantially equivalent to the predicate devices K103223 and K100048.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Non-clinical testing data that was submitted. referenced, or relied upon to demonstrate substantial equivalence included: component testing (tibial tray fatigue, contact area. contact stress, constraint, and tibial insert-tray interlock strength); UHMWPE material characterization (density, swell ratio, oxidation index, trans-vinylene index, melting point, crystallinity, vitamin E content, free-radical content, assessment of consolidation by scanning electron microscopy, and analysis of extraction residues); UHMWPE mechanical testing (Izod impact resistance, tensile properties, compressive properties, small punch testing, fatigue crack propagation, and environmental stress cracking); and force-control wear testing according to the methods of ISO 14243-1 and ISO 14243-2.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, the A200 Knee System has the following similarities to the predicate devices:

. has the same intended use,
. uses the same operating principles.
. incorporates the same basic designs,
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

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

February 14, 2013

Renovis Surgical Technologies, LLC % Paxmed International, LLC Kevin Thomas, Ph.D. 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K120038

Trade/Device Name: A200 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: OIY, JWH Dated: January 29, 2013 Received: January 30, 2013

Dear Dr. Thomas:

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

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Page 2 - Kevin Thomas, Ph.D.

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.

Sincerelv vours.

Image /page/4/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters "Erin" and "eith" are in a standard font, while the letters "D" and "K" are stylized with a layered, outlined design. The dot in the "I" is a solid black circle.

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

Enclosure

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510(k) Summary K120038

Indications for Use

510(k) Number: K120038

Device Name: A200 Knee System

The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for cemented use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

013.02.08 14:36:18 Anton E. Dmitriev, PhD 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.