The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
Device Story
Plate and screw system for mandible trauma and reconstruction; plates attach to bone via self-tapping cortex or locking screws; features internally threaded compression screw holes; instrumentation includes threaded drill guides for drill bit alignment and insert screws to protect threaded holes during plate bending; device provided non-sterile; requires moist heat sterilization per AAMI guidelines; used by surgeons in clinical settings; provides mechanical stabilization of bone segments.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Materials: unspecified metal plate and screw system; dimensions: 2.4 mm system with 2.4 mm - 3.0 mm locking screws; drill guides (1.5 mm - 2.5 mm bores); sterilization: moist heat (steam) per AAMI guidelines; non-sterile delivery.
Indications for Use
Indicated for patients requiring mandible trauma repair or reconstruction procedures.
Regulatory Classification
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Predicate Devices
Synthes 2.7 mm Reconstruction Plate System
Submission Summary (Full Text)
{0}
SYNTHES
K961421
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301
JUN 26 1996
(610) 647-9700
Contact: Angela Silvestri
April 1996
Device: Synthes 2.4 mm Universal Locking Plate System, as compared to Synthes 2.7 mm Reconstruction Plate System.
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws.
The following instrumentation is used with the 2.4 mm ULPS:
Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm.
2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance."
Based on mechanical test results, we believe that the devices are at least equivalent.
