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Found 14 results
510(k) Data Aggregation
K Number
K190599Device Name
Aptis Medical Distal Radio Ulnar Joint Implant
Manufacturer
Aptis Medical, LLC
Date Cleared
2019-05-03
(56 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- · Pain and weakness of the wrist joint not improved by non-operative treatment
- · Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radio ulnar joint
- · Failed ulnar head resection; e.g. Darrach resection
- · Primary replacement after fracture of the ulnar head or neck.
- · Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
Device Description
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.
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K Number
K142569Device Name
Aptis Medical Distal Radio Ulnar Joint Implant
Manufacturer
APTIS MEDICAL, LLC.
Date Cleared
2015-04-03
(203 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aptis Medical Distal Radio Ulnar Joint implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
- Failed ulnar head resection; e.g. Darrach resection
- Primary replacement after fracture of the ulnar head or neck.
- Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
Device Description
The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including; Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head. The device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna.
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K Number
K112481Device Name
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
Manufacturer
ASCENSION ORTHOPEDIC
Date Cleared
2012-04-09
(224 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.
The First Choice Partial Ulnar Head implant is intended for press-fit use.
Device Description
The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.
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K Number
K081025Device Name
ISOELASTICU
Manufacturer
REMI SCIENCES, INC.
Date Cleared
2008-11-21
(225 days)
Product Code
KXE, KXF
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications
- -Rheumatoid arthritis with or without tendon ruptures
- -Degenerative arthritis or post traumatic arthritis
- 1. Arthrofibrosis of the DRUJ o
- 2. Reconstruction of the distal ulna post tumor resection o
- 3. Failed Ulnar Head Resection 0
- 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
- 5. Revision following failed ulnar head arthroplasty O
- Ulna stems are intended for uncemented use -
Device Description
The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.
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K Number
K082839Device Name
DISTAL RADIO-ULNAR JOINT IMPLANT
Manufacturer
APTIS MEDICAL, LLC.
Date Cleared
2008-10-24
(28 days)
Product Code
KXE, COM
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
- Failed ulnar head resection; eg. Darrach resection
- Primary replacement after fracture of the ulnar head or neck.
- Revision following failed ulnar head arthroplasty.
Device Description
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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K Number
K061146Device Name
SBI ULNAR HEAD IMPLANT
Manufacturer
SMALL BONE INNOVATIONS INC.
Date Cleared
2006-07-19
(85 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.
Device Description
The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.
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K Number
K053119Device Name
DISTAL RADIO-ULNAR JOINT IMPLANT
Manufacturer
APTIS MEDICAL, LLC.
Date Cleared
2005-12-07
(30 days)
Product Code
KXE, COM, ORI
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment .
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint
- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .
Device Description
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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K Number
K052137Device Name
ASCENSION MUH
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2005-11-03
(90 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® MUH is intended for replacement of the distal radioulnar joint:
Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:
- Pain and weakness of the wrist joint not improved by conservative treatment .
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
- Failed ulnar head resection .
Device Description
The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.
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K Number
K040497Device Name
DISTAL RADIO-ULNAR JOINT IMPLANT
Manufacturer
APTIS MEDICAL, LLC.
Date Cleared
2005-01-26
(335 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
- Failed ulnar head resection; eg. Darrach resection
- Primary replacement after fracture of the ulnar head or neck.
- Revision following failed ulnar head arthroplasty.
Device Description
The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.
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K Number
K042902Device Name
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
Manufacturer
STUCKENBROCK MEDIZINTECHNIK GMBH
Date Cleared
2004-12-27
(68 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Product Code :
KXE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
Device Description
The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.
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