The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.

Device Description

The KeriFlex® Finger Joint Prostheses are flexible, one-piece, hinged silicone elastomer implants designed to be implanted across the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed.

The KeriFlex® Finger Joint Prostheses are single-use devices indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative, or traumatic arthritis. The KeriFlex® Finger Prostheses are provided sterile and are intended to be single use.

The associated instruments include:

Patterns to be used prior to the bone cut to identify the resection level and to identify the definitive implant.
Starter (awl) to help the surgeon prepare the implantation site.
Rasps to help the surgeon prepare the implantation site.
Sterilization tray, lid, insert and rack which protect the instruments during transportation and sterilization.

AI/ML Overview

The provided text is a 510(k) summary for the KeriFlex® MCP and PIP Finger Joint Prostheses. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document states:

The device is a physical medical implant (finger joint prostheses).
The performance data listed (Fatigue Test, Material Characterization, Range of Motion) are typical engineering and biomechanical tests for an implant, not studies on AI/algorithm performance or reader improvement with AI assistance.
The submission aims to demonstrate substantial equivalence to predicate devices, focusing on similar technological characteristics, materials, and intended use, not on diagnostic accuracy or AI-driven improvements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets acceptance criteria for an AI/algorithm. The information is not present in the provided text.

Summary

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Keri Medical SA Bernard Prandi President Route des Acacias. 45a Geneva. CH-1227 Switzerland

Re: K211385

Trade/Device Name: KeriFlex® MCP and PIP Finger Joint Prostheses Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KYJ Dated: June 24, 2022 Received: June 24, 2022

Dear Bernard Prandi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

July 27, 2022

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Jiping Chen, MD, Ph.D., M.P.H. Acting Division Director DHT6A:Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211385

Device Name KeriFlex® MCP and PIP Finger Joint Prostheses

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	KeriFlex® MCP and PIP Finger Joint Prostheses
Manufacturer:	Keri Medical SARoute des Acacias, 45aCH-1227 GenevaSwitzerland
Contact:	Bernard PrandiPresident+41 58 255 01 30
Prepared by:	Mehdi Kazemzadeh-Narbat, PhD, PMP, CQAAssociate Director, Regulatory AffairsMCRA, LLC803 7th, Street NW, Floor 3Washington, DC 20001Office: 202.552.6011mkazemzadeh@mcra.com
Date Prepared:	July 27, 2022
Classifications:	Finger Joint Polymer Constrained Prosthesis, under 21 CFR 888.3230
Class:	II
Product Code:	KYJ
Predicate Devices:	DePuy Orthopaedics' NeuFlex PIP Finger Joint Prosthesis (K083107)DePuy Orthopaedics' MCP Finger Joint Prosthesis (K970544)

Indications for Use:

Device Description:

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degenerative, or traumatic arthritis. The KeriFlex® Finger Prostheses are provided sterile and are intended to be single use.

The associated instruments include:

၊ Patterns to be used prior to the bone cut to identify the resection level and to identify the definitive implant.
Starter (awl) to help the surgeon prepare the implantation site.
Rasps to help the surgeon prepare the implantation site.
Sterilization tray, lid, insert and rack which protect the instruments during transportation and sterilization.

Comparison of Technological Characteristics:

The subject and predicate devices have intended use, have similar technological characteristics and geometries, and are made of similar materials.

	Device	MCP Finger JointProsthesis(K970544)	NeuFlex PIP FingerJoint Prosthesis(K083107)	Subject Device(KERIFLEX®)
	Manufacturers	DEPUY INC.	DEPUY INC.	KERIMEDICAL
	RegulationCFR classification	888.3230
	Product code	KYJ
	Indication for use	The DePuy DuPontOrthopaedics FingerJoint Prosthesis isindicated forcementlessreplacement of themetacarpophalangeal(MCP) joints of thefinger where disabledby rheumatoid,degenerative ortraumatic arthritis	The DePuy DuPontOrthopaedicsFinger JointProsthesis isindicated forcementlessreplacement ofthe proximalinterphalangeal(PIP) joints of thefinger wheredisabled byrheumatoid,degenerative ortraumatic arthritis	The KeriFlex® Finger JointProstheses are devices indicatedfor cementless replacement ofthe metacarpophalangeal (MCP)and interphalangeal (PIP) joints,respectively, where disabled byrheumatoid, degenerative ortraumatic arthritis.
Design	Material	Silicone elastomer
	Sizes	12 sizes5 implants for the interphalangeal (PIP)7 implants for metacarpo-phalangeal (MCP)
	Angle (°)	30°C for MCP	15° for PIP	30°C for MCP and 15° for PIP
Ancillaries	Material	Silicone Elastomer

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	12 sizes5 implants for the interphalangeal (PIP)7 implants for metacarpo-phalangeal (MCP)
Sterility	Sterile (Plasma Gas)	Sterile (ETO)
Single-Use	Yes
Shelf Life	5 years

Performance Data:

The following performance testing was performed on the KeriFlex® devices:

Fatigue Test
Material Characterization ●
. Range of Motion

Conclusion:

The subject and predicate devices have intended use, have similar technological characteristics and geometries, and are made of similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 888.3230 Finger joint polymer constrained prosthesis.

(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.