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
Jazz Spinal System	634375	FDA UDI	Class II	Active
Squale	580017	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
JAZZ System	JAZZ Claw – Straight Rod Dia. 4/5.5 L70 - CoCr	FDA UDI	Class II	Active
Implanet Spine System	Thoracic hook—angled left	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.7.5 L40	FDA UDI	Class II	Active
Jazz Spinal System	633600	FDA UDI	Class II	Active
JAZZ System	Cap SP anti-torque wrench	FDA UDI	Class II	Active
Madison	UC insert trial size 7 - 16mm	FDA UDI	Class II	Active
Implanet Spine System	Dual Monoaxial Screw	FDA UDI	Class II	Active
Madison	Madison BL Spacer Plate 12mm	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	UC insert trial size 1 - 16mm	FDA UDI	Class II	Active
JAZZ System	Jazz Screw - Polyaxial Screw Dia.7.5 L60	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
JAZZ System	Instruments Container Gen.II - Basis	FDA UDI	Class I	Active
Implanet Spine System	Straight Union Rod CoCr	FDA UDI	Class II	Active
Madison	Femoral AP ML sizing guide - S8	FDA UDI	Class I	Active
JAZZ System	JAZZ Screw - Polyaxial Screw Dia.5 L35	FDA UDI	Class II	Active
JAZZ System	JAZZ Claw – Hook Left Large	FDA UDI	Class II	Active
Implanet Spine System	Straight Union Rod	FDA UDI	Class II	Active
JAZZ Lock	JAZZ Lock Tensioner Stem	FDA UDI	Class II	Active
JAZZ System	JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L35	FDA UDI	Class II	Active
Implanet Spine System	Polyaxial Pedicle Screw	FDA UDI	Class II	Active
Madison	Patella stylus	FDA UDI	Class I	Active
Implanet Spine System	X-Ray Marker Right	FDA UDI	Class I	Active
Madison	PS notch cutting block - S2	FDA UDI	Class I	Active
Madison	Universal UC insert Size 4 - 20 mm	FDA UDI	Class II	Active
JAZZ System	Jazz Rod - Pre-bent Union Rod Dia.6.0 L60	FDA UDI	Class II	Active
Squale	380002	FDA UDI	Class II	Active
Madison	Cemented fixed tibial base S5	FDA UDI	Class II	Active
Madison	UC insert trial size 4 - 20mm	FDA UDI	Class II	Active
Madison	LB jumper 2-4	FDA UDI	Class I	Active
Madison	Tibial baseplate and insert impactor	FDA UDI	Class II	Active
Madison	UC insert trial size 7 - 14mm	FDA UDI	Class II	Active
Madison	PS notch cutting block - S7	FDA UDI	Class I	Active
Implanet Spine System	Monoaxial Pedicle Screw	FDA UDI	Class II	Active
Jazz Frame	JAZZ Frame - T-Bar Dia.4,5 L30	FDA UDI	Class II	Active
Implanet Spine System	Prebent Union Rod	FDA UDI	Class II	Active
Madison	Madison articulated patellar tip	FDA UDI	Class I	Active
Madison	Large resection check	FDA UDI	Class I	Active
Madison	Tibial Stem Cap	FDA UDI	Class II	Unknown
Madison	Cemented patella Ø 39/10	FDA UDI	Class II	Active
Madison	Femoral AP ML sizing guide - S5	FDA UDI	Class I	Active
Madison	Tibial trial baseplate - S5	FDA UDI	Class II	Active
Madison	Femoral AP ML sizing guide - S1	FDA UDI	Class I	Active
Madison	Universal UC insert Size 6 - 10 mm	FDA UDI	Class II	Active

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