Identity
- Trade Name
- SuperSTEP™ FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- 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 06mm 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. FDA UDI
- Model / Reference
- 20063 FDA UDI
- 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 20mm with a 06mm 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. FDA UDI
Identifiers
- Catalog Number
- 20063 FDA UDI
- Primary DI / UDI-DI
- M963200630 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone staple, non-adjustable
SuperSTEP™ by Metric Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone staple, non-adjustable.
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- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · 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 10b94013-91aa-4dfa-8a1c-28e6ae93e41d 37 fields · synced May 31, 2026