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510(k) Data Aggregation
K Number
K240049Device Name
LINK(TM) External Fixator
Manufacturer
Metric Medical Devices, Inc.
Date Cleared
2024-05-29
(142 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Metric Medical Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Device Description
The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone.
In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins.
The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.
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K Number
K152627Device Name
IFS Fixation Scaffold System
Manufacturer
METRIC MEDICAL DEVICES, INC.
Date Cleared
2016-01-13
(120 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
METRIC MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IFS Fixation Scaffold is indicated for small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes.
Device Description
The IFS is a hollow fenestrated cylinder fabricated from nitinol with a section that increases the implants diameter to lock into the medullary compartment of bone while shortening its length. The nitinol's transition temperatures are set so that the material is in the austenitic state when released at room temperature. Features on the cylinder's surface, such as bulges and prongs, lock into bone.
The IFS is pre-loaded onto an insertion instrument and held elongated in position by a lock plate. During insertion, the IFS is released by turning a knob on its instrument while the lock plate both releases the IFS and limits the depth of implant insertion.
The IFS implants range in diameter from 2.5 to 4.5 mm and up to 9.3 mm when expanded and range in length from 21 to 27 mm depending on size and extent of contraction.
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K Number
K123363Device Name
SUPER STAPLE(TM) CLASSIC
Manufacturer
METRIC MEDICAL DEVICES, INC.
Date Cleared
2013-01-03
(63 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
METRIC MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Device Description
The Super Staple™ is a two leg U-shaped staples fabricated from nitinol alloy with an S-shaped bridge design. These U-shaped compressive staples range in width from 9 to 30 millimeters. Staple prong length ranges from 7 to 30 mm and staples have prongs of equal and unequal length.
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