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510(k) Data Aggregation
K Number
K211385Device Name
KeriFlex® MCP and PIP Finger Joint Prostheses
Manufacturer
Keri Medical SA
Date Cleared
2022-07-27
(449 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
Applicant Name (Manufacturer) :
Keri Medical SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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