Question 1

What types of medical devices does Implanet manufacture?

Accepted Answer

Implanet specializes in spinal and orthopaedic devices. Their portfolio includes systems for spinal stabilization like trans-facet screws, internal spinal fixation rods, polymeric interbody fusion cages, and cable tensioners. They also produce cruciate-retaining total knee prostheses, reusable orthopaedic surgical kits, and instrument trays designed for orthopaedic procedures. These devices are primarily used in spinal and joint surgeries to provide structural support and promote healing.

Question 2

Where is Implanet based?

Accepted Answer

Implanet is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA). This means their devices must adhere to FDA guidelines and regulations for classification, listing, and post-market surveillance.

Question 3

Which regulatory registries list Implanet’s devices?

Accepted Answer

Implanet’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability, regulatory compliance, and transparency in the healthcare system. Listing in this database is required for Class I and Class II devices in the U.S.

Question 4

How are Implanet’s devices classified by the FDA?

Accepted Answer

Implanet’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and are typically exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as spinal or joint stabilization.

Question 5

Why does the classification of Implanet’s devices matter?

Accepted Answer

The FDA classification determines the regulatory pathway a device must follow before it can be marketed. For example, Class II devices like some of Implanet’s spinal fixation systems require premarket submissions to demonstrate compliance with FDA regulations, ensuring they meet performance standards and safety requirements. This classification helps healthcare providers and regulators assess the risk associated with the device, influencing how it is used in clinical settings and monitored post-market.

Device	Model / Reference	Registries	Class	Status
Implanet Spine System	Straight Rod CoCr	FDA UDI	Class II	Active
Madison	Container base lid 4	FDA UDI	Class I	Active
JAZZ System	JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L25	FDA UDI	Class II	Active
JAZZ System	JAZZ Passer Band	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.6 L35	FDA UDI	Class II	Active
Squale	580006	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Jazz Lock	JAZZ LOCK- Sterilization tray - Basis	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
JAZZ System	Tensioner Gen. II - 120° Low Profile Stem	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.6.5 L60	FDA UDI	Class II	Active
Implanet Spine System	Dual Monoaxial Screw	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Madison	UC insert trial size 2 - 20mm	FDA UDI	Class II	Active
Madison	Patella trial 4 - 10mm	FDA UDI	Class II	Active
Madison	Ankle clamp - Part 1/2	FDA UDI	Class I	Active
Madison	Patella trial 2 - 10mm	FDA UDI	Class II	Active
Madison	Universal UC insert Size 7 - 20 mm	FDA UDI	Class II	Active
JAZZ System	JAZZ PF - 5,5mm Connector Kit	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	PS notch cutting block - S8	FDA UDI	Class I	Active
Madison	Tibial stem Ø13 mm length 35 mm	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Implanet Spine System	Transverse Connector	FDA UDI	Class II	Active
Implanet Spine System	Monoaxial Pedicle Screw	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Madison	4° Right tibial ML cutting block	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	Madison Curved Osteotome	FDA UDI	Class I	Active
JAZZ System	Jazz Screw - Monoaxial Screw Dia.7 L40	FDA UDI	Class II	Active
Implanet Spine System	Dual Polyaxial Screw	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
JAZZ System	JAZZ LOCK- Sterilization tray - Lid	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Madison	Cemented patella Ø 39/8	FDA UDI	Class II	Active
Madison	LB jumper S3	FDA UDI	Class I	Active
Squale	580022	FDA UDI	Class I	Active
Madison	Pin box lid	FDA UDI	Class I	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Implanet Spine System	Pedicular hook—long blade	FDA UDI	Class II	Active
Madison	Resection check	FDA UDI	Class I	Active
Implanet Spine System	Dual Polyaxial Screw	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Madison	Universal UC insert Size 2 - 14 mm	FDA UDI	Class II	Active
Squale	580018	FDA UDI	Class I	Active
JAZZ System	Jazz Rod - Straight Union Rod Dia.6.0 L160	FDA UDI	Class II	Active

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