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510(k) Data Aggregation
K Number
K171624Device Name
IXOS Radius Plate System
Manufacturer
Stuckenbrock Medizintechnik GmbH
Date Cleared
2018-03-29
(300 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Stuckenbrock Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.
It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly
- · Type A2 Colles fractures
- · Type A3 fractures
- · Type B1 fractures
- · Type B2 Barton fractures
- · Type B3 Smith or reversed Barton fractures
- · Type C1 fractures
- · Type C2 fractures
- · Type C3 fractures
and in osteotomies of the distal radius.
Device Description
The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.
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K Number
K171628Device Name
HBS2 Headless Bone Screw
Manufacturer
Stuckenbrock Medizintechnik GmbH
Date Cleared
2018-01-12
(224 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Stuckenbrock Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HBS2 Headless Bone Screw is used for the treatment of intraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:
HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures of the processus styloideus ulnae, Proximal radial head fractures
HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures of the processus styloideus radii
Device Description
The HBS2 Headless Bone Screws are used in the field of hand surgery, accident surgery and reconstructive surgery, and in orthopedics for the treatment of intraarticular and extra articular fractures and pseudo arthroses of small bone fragments, and for arthrodesis on small joints.
The system consists of various screws and instruments for different treatment options.
HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths.
HBS2 MIDI screws (magenta) are available with a diameter of 2.0 mm (shaft) and in different lengths. HBS2 MINI screws (green) are available with a diameter of 1.7 mm (shaft) and in different lengths too.
These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.
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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?
Applicant Name (Manufacturer) :
STUCKENBROCK MEDIZINTECHNIK GMBH
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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