SuperScaffold™

FDA UDI

Class II (US FDA UDI)

by Metric Medical Devices, Inc.

Identity

Trade Name: SuperScaffold™ FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2265L3 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 2265L3 FDA UDI
Primary DI / UDI-DI: M9632265L30 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 6.5 Millimeter FDA UDI
Outer Diameter — 2.20 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

SuperScaffold™ by Metric Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Metric Medical Devices, Inc.

Sources (1)

FDA UDI c25b66a6-e743-41d7-a1d6-79fa80c1cc58 37 fields · synced Jun 8, 2026