(449 days)
Not Found
No
The description focuses on the physical characteristics and mechanical performance of a silicone elastomer implant and associated surgical instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for permanent replacement of joints disabled by arthritis, which directly treats the condition and restores function.
No
The device is a medical implant (prosthesis) designed for cementless replacement of finger joints, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of silicone elastomer and includes associated surgical instruments, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The KeriFlex® Finger Joint Prostheses are implants designed to replace damaged joints within the body. They are surgically inserted and function mechanically.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is entirely within the body.
Therefore, the KeriFlex® Finger Joint Prostheses fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
KYJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpophalangeal (MCP) and interphalangeal (PIP) joints of the finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance testing was performed on the KeriFlex® devices:
- Fatigue Test
- Material Characterization
- . Range of Motion
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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
1
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
2
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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3
510(k) Summary
| Device Trade Name: | KeriFlex® MCP and PIP Finger Joint Prostheses |
|---|---|
| Manufacturer: | Keri Medical SA |
| Route des Acacias, 45a | |
| CH-1227 Geneva | |
| Switzerland | |
| Contact: | Bernard Prandi |
| President | |
| +41 58 255 01 30 | |
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA |
| Associate Director, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th, Street NW, Floor 3 | |
| Washington, DC 20001 | |
| Office: 202.552.6011 | |
| mkazemzadeh@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:
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,
4
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
Prosthesis
(K970544) | NeuFlex PIP Finger
Joint Prosthesis
(K083107) | Subject Device
(KERIFLEX®) |
|-------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturers | DEPUY INC. | DEPUY INC. | KERIMEDICAL |
| | Regulation
CFR classification | 888.3230 | | |
| | Product code | KYJ | | |
| | Indication for use | The DePuy DuPont
Orthopaedics Finger
Joint Prosthesis is
indicated for
cementless
replacement of the
metacarpophalangeal
(MCP) joints of the
finger where disabled
by rheumatoid,
degenerative or
traumatic arthritis | The DePuy DuPont
Orthopaedics
Finger Joint
Prosthesis is
indicated for
cementless
replacement of
the proximal
interphalangeal
(PIP) joints of the
finger where
disabled by
rheumatoid,
degenerative or
traumatic arthritis | The KeriFlex® Finger Joint
Prostheses are devices indicated
for cementless replacement of
the metacarpophalangeal (MCP)
and interphalangeal (PIP) joints,
respectively, where disabled by
rheumatoid, degenerative or
traumatic arthritis. |
| Design | Material | Silicone elastomer | | |
| | Sizes | 12 sizes
5 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 | | |
5
| | Sizer | 12 sizes
5 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.