SuperSTEP™ 20103

GUDID M963201030

Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula, and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol SuperSTEP™ staple implant of dimensions 20 x 20 x 20mm with a 10mm vertical step with a 2.0mm x 3.0mm leg diameter leg/bridge held in the instrument with a locking pin; 1ea 20mm spaced drill guide with step alignment pin, pre-assembled; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red).

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: M963201030
• NIH Device Record Key: 0bdf1bcf-cc81-473f-b1cc-f427f48353d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperSTEP™
• Version Model Number: 20103
• Catalog Number: 20103
• Company DUNS: 830255506
• Company Name: METRIC MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.
• Special Storage Condition, Specify: Between 0 and 0 *Staples and instruments should not be subjected to storage or shipping temperatures in excess of 76.7°C or 170°F.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M963201030 [Primary]

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-23
• Device Publish Date: 2018-09-07

On-Brand Devices [SuperSTEP™]

• M963201030: Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joi
• M963200830: Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joi
• M963200630: Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joi