Question 1

What types of medical devices does Zimmer, Inc. primarily manufacture?

Accepted Answer

Zimmer, Inc. specializes in orthopaedic devices, focusing on implants and surgical tools. Their portfolio includes reusable instruments like prosthesis implantation positioning tools, tibial inserts, and polyethylene acetabular liners. They also produce trial components for knee and hip prostheses, such as knee tibia and acetabulum prosthesis trials, as well as intramedullary nails for femur fixation. Additionally, they offer sterilization/disinfection containers for surgical instruments, ensuring reusable devices remain safe for repeated use.

Question 2

Where is Zimmer, Inc. based, and where are its devices developed and distributed?

Accepted Answer

Zimmer, Inc. is based in the United States. The company develops and distributes its orthopaedic devices from this location, serving global markets with products designed for orthopaedic surgeries, including hip and knee replacements, as well as fracture fixation.

Question 3

Which regulatory registries list Zimmer, Inc.’s devices?

Accepted Answer

Zimmer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices, allowing healthcare providers and regulators to identify and track specific products by their unique identifiers.

Question 4

How are Zimmer, Inc.’s orthopaedic devices classified under FDA regulations?

Accepted Answer

Zimmer, Inc.’s devices fall into three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class III (high-risk devices requiring pre-market approval). The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as implants for joint replacement or intramedullary nails for bone fixation.

Question 5

What reasoning determines why Zimmer’s devices are classified under different FDA categories?

Accepted Answer

The FDA categorizes medical devices based on the level of risk they pose and the regulatory controls needed to ensure safety and performance. For example, reusable positioning instruments for prosthesis implantation are typically Class II due to their role in precise surgical procedures, requiring validation of their design and manufacturing processes. In contrast, intramedullary nails for femur fixation may be Class III because they are implanted within the body and carry higher risks, necessitating rigorous pre-market approval to confirm their safety and efficacy.

Device	Model / Reference	Registries	Class	Status
Natural Nail®	00-2490-090-11	FDA UDI	Class II	Active
Z1™ Hip System	611889010	FDA UDI	Class II	Active
Wagner Cone Prosthesis®	01.00561.213	FDA UDI	Class II	Active
FuZion	SSI004777	FDA UDI	Class I	Active
Zimmer® Natural Nail® System	47-2493-301-11	FDA UDI	Class II	Active
Trabecular Metal®	00-4309-071-40	FDA UDI	Class I	Active
Natural-Knee®	6705-01-913	FDA UDI	Class II	Active
Bigliani Flatow	SSI005199	FDA UDI	Class I	Active
Trilogy®	6120-58-28	FDA UDI	Class II	Active
Persona Tibia Cut Block Adapter with 2 Degrees V/V	SSI007593	FDA UDI	Class I	Active
Vang CR Fem TRL W Pin Hole 72.5MM LT	SSI002081	FDA UDI	Class I	Active
Identity™	SAHH5726T	FDA UDI	Class II	Active
Orthopedic	SSI005236	FDA UDI	Class I	Active
Ncb®	02.03150.310	FDA UDI	Class II	Active
Ncb®	02.00024.006	FDA UDI	Class II	Active
HGPII Acetabular Component	32-6728-94-01	FDA UDI	Class II	Active
Herbert/Whipple®	1152-06	FDA UDI	Class II	Active
M/Dn®	2237-97	FDA UDI	Class I	Active
Vanguard® Vivacit-E®	VE189043	FDA UDI	Class II	Active
Alloclassic® Zweymüller® Sl	2842	FDA UDI	Class II	Active
Persona®	42-5046-058-11	FDA UDI	Class II	Active
Trabecular Metal®	00-5850-002-10	FDA UDI	Class II	Active
Anatomical Shoulder™ Domelock®	01.04558.218	FDA UDI	Class II	Active
Vivacit-E®	00-5842-091-09	FDA UDI	Class II	Active
Persona®	42-5381-008-01	FDA UDI	Class II	Active
Persona®	42-5860-012-10	FDA UDI	Class II	Active
PERSONA™ Natural Tibia™	42-5321-071-01	FDA UDI	Class II	Active
Continuum® Trilogy® Allofit® Longevity®	00-8752-011-36	FDA UDI	Class II	Active
Natural Nail®	47-2494-440-11	FDA UDI	Class II	Active
Trilogy®	6141-62-22	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5221-004-20	FDA UDI	Class II	Active
L2l®	00-8701-031-01	FDA UDI	Class I	Active
OsseoFit™ Stemless Shoulder	00-5381-003-10	FDA UDI	Class I	Active
TM Punch	SSI005896	FDA UDI	Class II	Active
HGPII Acetabular Component	32-6726-03-01	FDA UDI	Class II	Active
14.25x380mm Bullet-Tip Reamer	SSI006015	FDA UDI	Class I	Active
77mm Bridgeback Rmr	SSI006838	FDA UDI	Class I	Active
NexGen®	5976-30-20	FDA UDI	Class II	Active
Identity™	SAHS1112	FDA UDI	Class II	Active
Vanguard® Vivacit-E®	VE183480	FDA UDI	Class II	Active
Persona®	42-5558-013-05	FDA UDI	Class II	Active
CLS® Brevius® Kinectiv®	01.00296.112	FDA UDI	Class III	Active
NexGen	SSI004656	FDA UDI	Class II	Active
Alloclassic®	01.00129.125	FDA UDI	Class II	Active
Durasul®	4380-28-055	FDA UDI	Class II	Active
Natural Nail®	47-2495-280-09	FDA UDI	Class II	Active
Itst®	2257-500-02	FDA UDI	Class II	Active
Versa-Fx®	1193-145-96	FDA UDI	Class II	Active
Affixus®	815514380	FDA UDI	Class II	Active
Z1™ Hip System	611203060	FDA UDI	Class II	Active

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