KeriFlex® MCP and PIP Finger Joint Prostheses

K211385 · Keri Medical SA · KYJ · Jul 27, 2022 · Orthopedic

Device Facts

• Record ID: K211385
• Device Name: KeriFlex® MCP and PIP Finger Joint Prostheses
• Applicant: Keri Medical SA
• Product Code: KYJ · Orthopedic
• Decision Date: Jul 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3230
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

KeriFlex® Finger Joint Prostheses are flexible, one-piece, hinged silicone elastomer implants; designed for cementless replacement of MCP or PIP joints. Proximal and distal stems form an angle mimicking relaxed hand position (30° for MCP; 15° for PIP). Used by surgeons in clinical settings for patients with joint disability due to arthritis. Ancillary instruments include patterns for bone resection, starter awls, and rasps. Provided sterile for single-use. Implants restore joint function and mobility.

Clinical Evidence

Bench testing only. Performance data included fatigue testing, material characterization, and range of motion testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

One-piece hinged silicone elastomer implant. Cementless fixation. MCP version (30° angle), PIP version (15° angle). Provided sterile. Single-use. Includes stainless steel/metal ancillary instruments (patterns, awls, rasps).

Indications for Use

Indicated for patients requiring cementless replacement of MCP or PIP finger joints disabled by rheumatoid, degenerative, or traumatic arthritis.

Regulatory Classification

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.

Predicate Devices

• NeuFlex PIP Finger Joint Prosthesis (K083107)
• MCP Finger Joint Prosthesis (K970544)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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 SA<br>Route des Acacias, 45a<br>CH-1227 Geneva<br>Switzerland |
| Contact: | Bernard Prandi<br>President<br>[phone] |
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA<br>Associate Director, Regulatory Affairs<br>MCRA, LLC<br>803 7th, Street NW, Floor 3<br>Washington, DC 20001<br>Office: 202.552.6011<br>[e-mail] |
| 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)<br>DePuy Orthopaedics' MCP Finger Joint Prosthesis (K970544) |

## Indications for Use:

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,

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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 Joint<br>Prosthesis<br>(K970544) | NeuFlex PIP Finger<br>Joint Prosthesis<br>(K083107) | Subject Device<br>(KERIFLEX®) |
|-------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturers | DEPUY INC. | DEPUY INC. | KERIMEDICAL |
| | Regulation<br>CFR classification | 888.3230 | | |
| | Product code | KYJ | | |
| | Indication for use | The DePuy DuPont<br>Orthopaedics Finger<br>Joint Prosthesis is<br>indicated for<br>cementless<br>replacement of the<br>metacarpophalangeal<br>(MCP) joints of the<br>finger where disabled<br>by rheumatoid,<br>degenerative or<br>traumatic arthritis | The DePuy DuPont<br>Orthopaedics<br>Finger Joint<br>Prosthesis is<br>indicated for<br>cementless<br>replacement of<br>the proximal<br>interphalangeal<br>(PIP) joints of the<br>finger where<br>disabled by<br>rheumatoid,<br>degenerative or<br>traumatic arthritis | The KeriFlex® Finger Joint<br>Prostheses are devices indicated<br>for cementless replacement of<br>the metacarpophalangeal (MCP)<br>and interphalangeal (PIP) joints,<br>respectively, where disabled by<br>rheumatoid, degenerative or<br>traumatic arthritis. |
| Design | Material | Silicone elastomer | | |
| | Sizes | 12 sizes<br>5 implants for the interphalangeal (PIP)<br>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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| | Sizer | 12 sizes<br>5 implants for the interphalangeal (PIP)<br>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.