Acumed Small Bone Locking System II
FDA 510(k)Class II (US FDA 510(k))
by Acumed, LLC
Identifiers
- 510(k) Number
- K071944 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acumed Small Bone Locking System II is an intramedullary fixation device consisting of solid or cannulated rods and cortical screws. The rods are slightly bowed and range in length from millimeters with diameters of 3.0-4.5 mm.
It is used by surgeons in clinical settings to stabilize bone fractures and osteotomies of the fibula, radius, and ulna. The device is supplied non-sterile and requires sterilization prior to use. It is a reusable system and has received FDA 510(k) clearance under K071944.
Frequently asked questions
What is the Acumed Small Bone Locking System II used for?
It is used by surgeons in clinical settings to stabilize bone fractures and osteotomies of the fibula, radius, and ulna. The system includes solid or cannulated intramedullary rods and cortical screws designed for fixation in small bones.
How is the Acumed Small Bone Locking System II supplied and prepared for use?
The device is supplied non-sterile and must be sterilized by the user prior to surgical use. This requires appropriate sterilization procedures to be performed in a healthcare facility before implantation.
Is the Acumed Small Bone Locking System II reusable or single-use?
It is a reusable system, meaning the instruments and components can be cleaned, sterilized, and used in multiple surgical procedures, following validated reprocessing protocols.
What are the size specifications of the rods in the Acumed Small Bone Locking System II?
The rods range in length from millimeters and have diameters between 3.0 mm and 4.5 mm. They are slightly bowed to match anatomical contours and are available in solid or cannulated configurations.
What regulatory pathway was used for the Acumed Small Bone Locking System II?
The device received FDA 510(k) clearance under submission number K071944, indicating it was found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACUMED SMALL BONE LOCKING ROD SYSTEM II (K031438) — FDA 510 (k ..., PDF K071944 - Acumed Small Bone Locking System Ii, ACUMED SMALL BONE LOCKING SYSTEM II - Innolitics, Acumed | Surgical Orthopedic Fracture Fixation Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071944 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K071944 24 fields · synced Sep 21, 2026