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510(k) Data Aggregation
K Number
K243381Device Name
Total Wrist Arthroplasty System (TWA)
Manufacturer
Skeletal Dynamics Inc
Date Cleared
2024-11-01
(2 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.
Device Description
The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.
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K Number
K233574Device Name
Total Wrist Arthroplasty System (TWA)
Manufacturer
Skeletal Dynamics
Date Cleared
2024-07-03
(239 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.
Device Description
The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.
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K Number
K233674Device Name
Freedom Wrist Arthroplasty System
Manufacturer
Ascension Orthopedics, Inc.
Date Cleared
2024-05-30
(196 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.
Device Description
The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.
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K Number
K200718Device Name
Arthrosurface WristMotion Total Wrist Arthroplasty System
Manufacturer
Arthrosurface, Inc.
Date Cleared
2020-10-15
(210 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
The device is a single-use implant intended to be used with bone cement.
Device Description
The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.
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K Number
K191525Device Name
KinematX Total Wrist Arthroplasty System
Manufacturer
Extremity Medical, LLC.
Date Cleared
2020-03-04
(268 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:
1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
2. Revision where other devices or treatments have failed
3. Scapholunate Advanced Collapse (SLAC)
4. Rheumatoid Arthritis
The device is intended to be implanted with bone cement.
Device Description
The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:
1) Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
2) Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.
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K Number
K132250Device Name
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
Manufacturer
INTEGRA LIFE SCIENCES CORPORATION
Date Cleared
2014-03-24
(248 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.
Device Description
The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components:
- Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) .
- . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy
- . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe)
Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.
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K Number
K080426Device Name
MAESTRO WRIST FRACTURE IMPLANT
Manufacturer
BIOMET MANUFACTURING CORP.
Date Cleared
2008-07-29
(160 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis.
2) Rheumatoid arthritis.
3) Revision where other devices or treatments have failed.
4) Scapholunate Advanced Collapse (SLAC) and other functional deformities.
5) Trauma, including fractures of the distal radius and/or carpal bones.
The radial and carpal components are intended to be implanted with bone cement.
Device Description
The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.
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K Number
K042032Device Name
MAESTRO TOTAL WRIST
Manufacturer
BIOMET, INC.
Date Cleared
2004-10-07
(71 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
2) Rheumatoid arthritis
3) Revision where other devices or treatments have failed
4) Scapholunate Advanced Collapse (SLAC) and other functional deformities
5) Trauma, including fractures of the distal radius and/or carpal bones
The device is intended to be implanted with bone cement.
Device Description
The Maestro™ Total Wrist System consists of a two piece radial component with a molded bearing and a three-piece carpal component. The radial component is composed of a distal body with a modular stem. The distal bodies come in three sizes and have a molded polyethylene bearing surface. The stem is modular, assembled in the operating room by a screw assembly. The carpal component consists of a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement. Like the radial stems, the capitate stems screw to the plate and head.
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K Number
K031203Device Name
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Date Cleared
2003-07-14
(89 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the wrist joint.
The DePuy Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction
The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery.
CAUTION: The DePuy Biax A.F. Wrist System is for cemented use only.
Device Description
The Biax A.F. Wrist System is a cemented, multiple component system to be used for the treatment, and revision, of wrist joints:
• The radial implant stem is made of ASTM F-75 Orthochrome with an articulating surface of UHWMPe. It is available in small, medium and large sizes.
• The 5-piece metacarpal implant is manufactured from F-75 Orthochrome and Titanium (Ti-6Al-4V ELI). It consists of a fixation plate, cemented and held in place with a central stem and two peripheral screws, and attached to an articulating head. All parts are available in a variety of sizes.
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K Number
K030037Device Name
UNIVERSAL TOTAL WRIST SYSTEM
Manufacturer
KINETIKOS MEDICAL, INC.
Date Cleared
2003-02-05
(30 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Product Code :
JWJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.
Device Description
The KMI Universal Total Wrist (UTW) System (both predicate and extra small) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component, and two bone screws. The system will now be offered in 4 (four) sizes: 'extra small', 'small', 'medium' and 'large'), each with 3 (three) matching polymer component sizes, which are available in yarvina thicknesses (height); standard, +1 and + 2, It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW Surgical Protocol.
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