Question 1

What types of medical devices does AVANTI Orthopaedics LLC manufacture?

Accepted Answer

AVANTI Orthopaedics LLC specializes in orthopaedic fixation hardware, primarily focusing on devices used to stabilize bones during surgical procedures. Their product range includes cannulated and non-locking screws, non-bioabsorbable fixation plates, and reusable surgical instruments like drilling power tool attachments, osteotomy guides, and screwdrivers. They also produce single-use intraoperative positioning pins and reusable instrument trays, all designed to support orthopaedic surgeries.

Question 2

Where is AVANTI Orthopaedics LLC based, and what does that mean for their regulatory oversight?

Accepted Answer

AVANTI Orthopaedics LLC is based in the United States, which means their devices fall under the regulatory jurisdiction of the FDA. Since the company’s products are classified as Class II devices, they must comply with FDA requirements for safety and effectiveness, including pre-market submissions like 510(k) clearances and UDI registration to ensure traceability and transparency in the medical device supply chain.

Question 3

Which regulatory databases list AVANTI Orthopaedics LLC’s devices, and why is this important?

Accepted Answer

AVANTI Orthopaedics LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database records pre-market submissions demonstrating that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures each device can be uniquely identified throughout its lifecycle. This listing helps healthcare providers, regulators, and supply chain partners verify device compliance and traceability.

Question 4

How are AVANTI Orthopaedics LLC’s devices classified under FDA regulations, and what does this classification entail?

Accepted Answer

AVANTI Orthopaedics LLC’s devices are classified as Class II under FDA regulations, which means they pose moderate risk and require special controls to ensure their safety and effectiveness. This classification typically involves mandatory registration, listing, and adherence to performance standards or post-market surveillance requirements. While Class II devices do not require pre-market approval like Class III devices, they still undergo rigorous review through pathways like the 510(k) process to ensure they meet regulatory benchmarks.

Question 5

What kinds of orthopaedic procedures are AVANTI Orthopaedics LLC’s devices intended for?

Accepted Answer

AVANTI Orthopaedics LLC’s devices are designed for orthopaedic procedures involving bone fixation and stabilization, such as fracture repairs, joint replacements, and corrective osteotomies. Their cannulated screws, fixation plates, and reusable instruments are commonly used in surgeries like internal fixation of long bones, spinal procedures, and hand/wrist surgeries where precise alignment and secure attachment are critical. The reusable instruments are also tailored for sterile surgical environments to enhance efficiency and reduce contamination risks.

Device	Model / Reference	Registries	Class	Status
Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 26mm Long	CH3226	FDA UDI	Class II	Active
Spanning Plate	SPN08	FDA UDI	Class II	Active
Lag Screw, 3.2mm x 21mm Long	LG3221	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 20mm Long	CH2220	FDA UDI	Class II	Active
Non-Locking Screw, 2.7mm x 16mm Long	NS2716	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 46mm Long	CH3246	FDA UDI	Class II	Active
Lag Screw, 2.7mm x 23mm Long	LG2723	FDA UDI	Class II	Active
Square Driver, 1.7mm	SD17	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 60mm Long	CH4060	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 54mm Long	CH3254	FDA UDI	Class II	Active
Locking Screw, 2.7mm x 22mm Long	LS2722	FDA UDI	Class II	Active
Volar PEEK Plate, 3 Hole, Right	VPR03	FDA UDI	Class II	Active
Locking Screw, 2.7mm x 24mm Long	LS2724	FDA UDI	Class II	Active
Reduction Tool	RDTL	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 26mm Long	CH4026	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 50mm Long	CH3250	FDA UDI	Class II	Active
Locking Peg, 2.7mm x 14mm Long	PG2714	FDA UDI	Class II	Active
Cutting Guide, 6mm	CG06	FDA UDI	Class II	Active
Locking Screw, 2.7mm x 26mm Long	LS2726	FDA UDI	Class II	Active
Lag Screw, 3.2mm x 19mm Long	LG3219	FDA UDI	Class II	Active
Lid, Tool Side (USCD Sub-Component)	USLT	FDA UDI	Class II	Active
Block (CS00 Sub-Component)	CSBLK	FDA UDI	Class II	Active
Locking Peg, 2.7mm x 20mm Long	PG2720	FDA UDI	Class II	Active
Non-Locking Screw, 2.7mm x 18mm Long	NS2718	FDA UDI	Class II	Active
Saw Blade, MicroAire Compatible	SB9M	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 44mm Long	CH4044	FDA UDI	Class II	Active
Assembled Screw Driver, 1.7mm	AD17	FDA UDI	Class II	Active
Non-Locking Screw, 2.7mm x 28mm Long	NS2728	FDA UDI	Class II	Active
Far Cortical Locking Screw, 2.7mm x 14mm Long	FS2714	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 2.2mm x 18mm Long	CH2218	FDA UDI	Class II	Active
Volar PEEK Plate, 9 Hole, Left	VPL09	FDA UDI	Class II	Active
Bone Clamp Ulnar Shortening	BCUS	FDA UDI	Class II	Active
Straight Plate, 10 Hole	STP10	FDA UDI	Class II	Active
Volar Fixed Plate, Wide, 5 Hole, Right	VWR05	FDA UDI	Class II	Active
Lag Screw, 2.7mm x 18mm Long	LG2718	FDA UDI	Class II	Active
K-Wire, 1.1mm x 100mm Long	KW1100	FDA UDI	Class II	Active
Lag Screw, 2.7mm x 22mm Long	LG2722	FDA UDI	Class II	Active
Far Cortical Locking Screw, 2.7mm x 28mm Long	FS2728	FDA UDI	Class II	Active
Locking Screw, 2.7mm x 10mm Long	LS2710	FDA UDI	Class II	Active
Drill Guide, 2.0mm	DG20	FDA UDI	Class II	Active
Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 40mm Long	CH3240	FDA UDI	Class II	Active
Non-Locking Screw, 2.7mm x 10mm Long	NS2710	FDA UDI	Class II	Active
Cannulated Countersink, 4.0mm	SK40	FDA UDI	Class II	Active
Cannulated Hexalobular Driver, Size No. 7	CDH7	FDA UDI	Class II	Active
Fastener Caddy Block Screw	FSBS	FDA UDI	Class II	Active
Lag Screw, 2.7mm x 15mm Long	LG2715	FDA UDI	Class II	Active
Lag Screw, 3.2mm x 12mm Long	LG3212	FDA UDI	Class II	Active
Lag Screw, 2.7mm x 14mm Long	LG2714	FDA UDI	Class II	Active
Forearm Plate Caddy	FPCD	FDA UDI	Class II	Active
Cannulated Screw, 2.7mm x 26mm Long	CS2726	FDA UDI	Class II	Active

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