SuperSTEP™

Basic Information

• Brand Name: SuperSTEP™
• Primary DI: M963200830
• Version / Model: 20083
• Catalog Number: 20083
• Company Name: METRIC MEDICAL DEVICES, INC.
• Labeler DUNS: 830255506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 3
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: e71fff30-3c15-43a3-b0d7-306696be720e

Device Description

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 22mm with a 08mm 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 ; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red), 1ea Tamp.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDR	Staple, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M963200830	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20mm length Bridge, 20mm legs, 8mm step height, 2.0mmx3.0mm leg diameter

Storage Conditions

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