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
JAZZ System	Jazz Screw - Monoaxial Screw Dia.5 L55	FDA UDI	Class II	Active
Jazz Spinal System	634374	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.7 L35	FDA UDI	Class II	Active
Implanet Spine System	Prebent Union Rod	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Madison	Universal UC insert Size 7 - 10 mm	FDA UDI	Class II	Active
Madison	Maddison BL Right Lat Plate	FDA UDI	Class I	Active
Madison	Tibial punch guide	FDA UDI	Class I	Active
Implanet Spine System	Straight Rod CoCr	FDA UDI	Class II	Active
Implanet	Persuader	FDA UDI	Class II	Active
Madison	UC insert trial size 7 - 12mm	FDA UDI	Class II	Active
Madison	Tibial stem Ø 11 mm length 35 mm	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Madison	CR Femoral EVO trial - S2 / Right	FDA UDI	Class II	Active
Implanet Spine Sysetm	Rod template - L.100	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
Implanet Spine System	Dual Monoaxial Screw	FDA UDI	Class II	Active
Implanet Spine System	Prebent Union Rod	FDA UDI	Class II	Active
Squale	580008	FDA UDI	Class I	Active
Implanet Spine System	Dual Thoracic Hook, Angled Right	FDA UDI	Class II	Active
Madison	LB jumper S6	FDA UDI	Class I	Active
Madison	UC insert trial size 5 - 10mm	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
Squale	380009	FDA UDI	Class II	Active
Implanet Spine System	Pre-bent Union Rod	FDA UDI	Class II	Active
JAZZ System	Braid Puller Forceps	FDA UDI	Class II	Active
Madison	External tibial guide - Distal shaft	FDA UDI	Class I	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.5.5 L60	FDA UDI	Class II	Active
Madison	4° Left tibial cutting block	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	Universal UC insert Size 3 - 18 mm	FDA UDI	Class II	Active
Madison	Universal UC insert Size 6 - 14 mm	FDA UDI	Class II	Active
JAZZ System	Large Round Passer	FDA UDI	Class II	Active
Implanet Spine System	Torque Indicator	FDA UDI	Class I	Active
Madison	EVO femoral sizer 5-8	FDA UDI	Class II	Active
Madison	Semi open LB femoral cutting guide S4	FDA UDI	Class II	Active
Madison	4° Left tibial ML cutting block	FDA UDI	Class I	Active
Madison	Evo Femoral Sizer / Rotation-Base	FDA UDI	Class I	Active
Implanet Spine System	Prebent Union Rod	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Monoaxial Screw Dia.6 L50	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	UC insert trial size 4 - 18mm	FDA UDI	Class II	Active
JAZZ System	Jazz Rod - Straight Union Rod – L160	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Monoaxial Screw Dia.8 L50	FDA UDI	Class II	Active
Implanet Spine System	Prebent Union Rod	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.5.5 L50	FDA UDI	Class II	Active
Madison	UC insert trial size 6 - 10mm	FDA UDI	Class II	Active
Madison	External tibial guide - V positionner	FDA UDI	Class I	Active

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