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510(k) Data Aggregation
K Number
K233670Device Name
Ascension Silicone MCP; Ascension Silicone PIP
Manufacturer
Ascension Orthopedics, Inc.
Date Cleared
2023-12-14
(29 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Device Description
The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.
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K Number
K220142Device Name
BRM Digitalis Spacer
Manufacturer
BRM Extremities Srl
Date Cleared
2023-04-04
(441 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:
- Osteoarthrosis;
- Rheumatoid arthritis;
- Post traumatic arthritis.
The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
- Rheumatoid arthritis;
- Osteoarthritis;
- Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
- Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
- Destroyed articular surface(s).
Device Description
The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.
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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?
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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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K Number
K140453Device Name
OSTEOTEC SILICONE FINGER IMPLANT
Manufacturer
OSTEOTEC LTD
Date Cleared
2015-04-17
(417 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
Device Description
The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture.
The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements.
The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.
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K Number
K083107Device Name
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Date Cleared
2009-02-09
(112 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Device Description
The Modified DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the Modified DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.
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K Number
K082231Device Name
ASCENSION SILICONE PIP
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2009-01-12
(158 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Device Description
The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
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K Number
K022892Device Name
ASCENSION SILLICONE MCP
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2002-11-25
(87 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.
Device Description
The Ascension Silicone MCP is an anatomically designed, single-use, one-component hinged prosthesis designed to be implanted without hone cement across the metacarpophalangeal joint. It is made from flexible, injection-molded, medical grade silicone elastomer. The proximal and distal stems of the Ascension Silicone MCP are pre-flexed at 30° to match the approximate natural 30° flexion stance of the relaxed human hand.
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K Number
K013629Device Name
FINGER JOINT PROSTHESIS
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2002-01-25
(81 days)
Product Code
KYJ, SUT
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
Device Description
The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.
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K Number
K001922Device Name
DEPUY NEUFLEX PIP FINGER
Manufacturer
DEPUY, INC.
Date Cleared
2000-08-29
(67 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Device Description
The DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.
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K Number
K970544Device Name
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
Manufacturer
DEPUY, INC.
Date Cleared
1997-09-12
(212 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy DuPont Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Device Description
The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is a flexible, one-piece, hinged silicone elastomer implant designed to be implanted across the metacarpophalangeal (MCP) joint. The proximal and distal stems of the prosthesis form a 30° angle which mimics the approximate position of the joint when the hand is relaxed.
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