Question 1

What types of medical devices does Icotec manufacture?

Accepted Answer

Icotec specializes in spinal surgical devices, including polymeric spinal interbody fusion cages for cervical and lumbar regions, non-bioabsorbable spinal screws, fixation plates, and reusable surgical tools like bone taps and sterilization containers. Their portfolio also covers vertebral body prostheses, spinal fixation rods (made from titanium or carbon/PEEK composites), and advanced pedicle screw systems for internal spinal stabilization. These devices are designed to support spinal fusion, stabilization, and reconstruction procedures.

Question 2

Where is Icotec based, and what regulatory region does it serve?

Accepted Answer

Icotec is based in the United States. While the company’s headquarters are in the U.S., its devices are developed and marketed in compliance with U.S. medical device regulations, including FDA requirements. This means their products are designed to meet the standards and regulatory expectations of the American healthcare system.

Question 3

Which regulatory registries or databases list Icotec’s devices?

Accepted Answer

Icotec’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for spinal fusion and fixation products, allowing healthcare providers and regulators to identify and verify the devices in clinical and surgical settings. The UDI system is a key component of FDA compliance for medical devices in the U.S.

Question 4

How are Icotec’s devices classified under FDA regulations?

Accepted Answer

All of Icotec’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance unless they are exempt, demonstrating that they meet established regulatory standards for their intended use in spinal surgery.

Question 5

What is the primary purpose of Icotec’s spinal fixation and fusion devices?

Accepted Answer

Icotec’s devices are primarily designed for spinal fusion and stabilization procedures. Their polymeric interbody cages promote bone growth between vertebrae, while non-bioabsorbable screws, plates, and rods provide structural support to maintain alignment during healing. Devices like vertebral body prostheses and pedicle screw systems address complex spinal deformities or injuries by restoring stability and facilitating long-term recovery. These products are engineered to address specific anatomical needs in cervical, lumbar, and thoracic regions.

Device	Model / Reference	Registries	Class	Status
KONG-TL VBR System, KONG-TL VBR E, Container Base	44-080-1	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 12 x 16 mm	12-58-16-32-12-ITi	FDA UDI	Class II	Active
icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm	12-59-02509	FDA UDI	Class II	Active
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 50 mm	16-6023-55550	FDA UDI	Class II	Active
KONG-TL VBR System, Trial Implant, XL + ES, Ø 19 mm x 60 mm	44-005-60	FDA UDI	Class II	Active
icotec Lumbar Cage PLIF 4° / 25 mm x 07 mm	13-59-42507	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 48 mm	43-248	FDA UDI	Class II	Active
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 35 mm	16-6023-56535	FDA UDI	Class II	Active
KONG-C VBR System, Trial End Plate, 3° / 14 x 13 mm	43-143	FDA UDI	Class II	Active
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 30 mm	16-6023-56530	FDA UDI	Class II	Active
VADER Pedicle System, Cannulated Tap, Ø 5.5 mm	42-621	FDA UDI	Class II	Active
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com	42-700	FDA UDI	Class II	Active
icotec Ant. Cervical Plate, 1 Segmental, 28 mm	12-70-18-28	FDA UDI	Class II	Active
LightMore Pedicle System 6.0, Screw, Carbon/PEEK, Polyax., Noncann., Ø 7.5 x 55	16-6024-57555	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 12 x 12 mm	12-57-12-32-12-ITi	FDA UDI	Class II	Active
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 40 mm	16-6023-57540	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 13 x 16 mm	13-58-16-32-13-ITi	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 7 x 13 mm	12-41-0713	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 6 x 16 mm	12-41-0616	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 66 mm	43-266	FDA UDI	Class II	Active
VADER Pedicle System, Handle for deburrer, M6	42-894-1	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Ti, Curved, Ø 6.0 r120 x 70 mm	16-60-81207	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 130 mm	16-60-74513	FDA UDI	Class II	Active
KONG-TL VBR System, Trial End Plate, rectangular, M, 0° x 33 mm	44-001-00-33	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 6 x 13 mm	13-41-0613	FDA UDI	Class II	Active
KONG-TL VBR System, Pusher	44-071	FDA UDI	Class II	Active
KONG-C VBR M, Body, 30 mm	12-80-1330-0	FDA UDI	Class II	Active
VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm	42-596	FDA UDI	Class II	Active
KONG-TL VBR, End Plate, round, M and Screw, 0° x 33 mm	12-90-0033	FDA UDI	Class II	Active
VADER Pedicle System VADER Pedicle System 2/2 Container Base	42-861-1	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 6 x 13 mm	12-41-0613	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, Ø 6.0 r000 + r450 x 60/60 mm	16-60-70606-9	FDA UDI	Class II	Active
KONG-C VBR M, Body, 24 mm	12-80-1324-0	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 38 mm	43-238	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 50 mm	16-60-74505	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 15 x 12 mm	13-57-12-32-15-ITi	FDA UDI	Class II	Active
VADER Pedicle System, Template for L S-rods	42-896-3	FDA UDI	Class II	Active
icotec Lumbar Cage PLIF 0° / 25 mm x 13 mm	12-59-02513	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm	16-60-70003	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 130 mm	16-60-70013	FDA UDI	Class II	Active
icotec Pedicle System 6.0, Rod, Ti, Straight, Ø 6.0 r000 x 160 mm	16-60-90016	FDA UDI	Class II	Active
icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 40 mm	16-6022-98540	FDA UDI	Class II	Active
VADER Pedicle System, Navigated Pedicle Probe, straight, for 5.5 mm Screw	42-520N	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 34 mm	43-234	FDA UDI	N	Active
icotec Lumbar Cage, Lumbar Cage PLIF, Container Lid	38-60-2	EUDAMEDFDA UDI	Class II	Active
VADER Pedicle System, Trephine for Ø 7.5 mm Screw, Ø 7.5 mm	42-442-75	FDA UDI	Class II	Active
KONG-C VBR M, Body, 18 mm	12-80-1318-0	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 5 x 13 mm	13-41-0513	FDA UDI	Class II	Active
icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm	16-6022-98555	FDA UDI	Class II	Active
KONG-TL VBR, End Plate, round, M and Screw, 4° x 33 mm	12-90-0433	FDA UDI	Class II	Active

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