FDA.reportPublic FDA data

SuperScaffold™

Primary DI
M9632265L30
Brand
SuperScaffold™
Company
METRIC MEDICAL DEVICES, INC.
Model
2265L3
Catalog number
2265L3
Device description
"Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045"") double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use."
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9632265L30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Millimeter
Outer Diameter2.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
830.535.6300sales@metricmd.com

Regulatory Flags#

DUNS number
830255506
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9632565L30Intramedullary Fixation Scaffold (IFS)2565L32565L32016-12-13
M9632565S30Intramedullary Fixation Scaffold (IFS)2565S32565S32016-09-26
M9632585L30Intramedullary Fixation Scaffold (IFS)2585L32585L32016-12-13
M9632585S20Intramedullary Fixation Scaffold (IFS)2585S22585S22016-09-26
M9632585S30Intramedullary Fixation Scaffold (IFS)2585S32585S32016-12-13
M963IFS250Intramedullary Fixation Scaffold (IFS)IFS2.5IFS2.52016-09-26
M96316TT0LINK™ External Fixator16TT16TT2024-06-07
M96320TG0LINK™ External Fixator20TG20TG2024-06-07
M96320TT0LINK™ External Fixator20TT20TT2024-06-07
M96322000200LINK™ External Fixator2-2000202-2000202024-06-07
M9634H201020LINK™ External Fixator4H2010204H2010202024-06-07
M963C200LINK™ External FixatorC-20C-202024-06-07
M963CH20100LINK™ External FixatorCH2010CH20102024-06-07
M963174010Super Staple™ Classic17401174012016-09-26
M963200630SuperSTEP™20063200632018-09-07
M963200830SuperSTEP™20083200832018-09-07
M963201030SuperSTEP™20103201032018-09-07
M963166010Super Staple™ Classic16601166012017-10-31
M963168010Super Staple™ Classic16801168012016-09-26
M963169010Super Staple™ Classic16901169012016-09-26

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Primary DI, Brand, Company table
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