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
Affixus®	814965110	FDA UDI	Class II	Active
Trilogy®	6105-60-22	FDA UDI	Class II	Active
Ssi Dst Agmt Prov E 10mm	SSI006524	FDA UDI	Class I	Unknown
Durasul®	4377-32-081	FDA UDI	Class II	Active
Zmr®	00-9924-045-78	FDA UDI	Class II	Active
Natural-Knee®	6277-08-201	FDA UDI	Class II	Active
Ncb®	02.02264.015	FDA UDI	Class II	Active
Persona® The Personalized Knee®	42-5176-007-07	FDA UDI	Class II	Active
Nexgen®	00-5886-064-10	FDA UDI	Class II	Active
Trilogy® Longevity®	6305-74-22	FDA UDI	Class II	Active
M/Dn®	2253-52-42	FDA UDI	Class II	Active
Apr®	4338-32-059	FDA UDI	Class II	Active
Premier-Total™	9351-30-011	FDA UDI	Class I	Unknown
Persona®	42-5700-060-01	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5121-008-20	FDA UDI	Class II	Active
Zimmer® Natural Nail® System	47-2493-303-13	FDA UDI	Class II	Active
Ncb®	02.03158.038	FDA UDI	Class II	Active
Biolox® Option	00-8777-032-04	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5221-009-13	FDA UDI	Class II	Active
Natural Nail®	00-2490-070-00	FDA UDI	Class I	Active
Persona® The Personalized Knee®	42-5360-088-01	FDA UDI	Class II	Active
Nexgen® Trabecular Metal®	00-5448-004-27	FDA UDI	Class II	Active
Natural-Knee®	6279-08-112	FDA UDI	Class I	Active
Persona®	42-5007-062-01	FDA UDI	Class II	Active
VerSys®	7843-16-08	FDA UDI	Class II	Active
Trabecular Metal®	00-7865-010-14	FDA UDI	Class I	Active
NexGen® Gender Solutions®	00-5755-013-06	FDA UDI	Class I	Active
NexGen®	00-5903-023-41	FDA UDI	Class I	Active
Persona®	42-5112-001-20	FDA UDI	Class II	Active
Natural Nail	SSI004786	FDA UDI	Class I	Active
Natural-Knee®	6230-08-140	FDA UDI	Class II	Active
Natural-Knee®	6118-06-011	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5126-001-10	FDA UDI	Class II	Active
Cpt®	8114-04-20	FDA UDI	Class II	Active
M/Dn®	2258-71-45	FDA UDI	Class I	Active
Affixus®	211300002	FDA UDI	Class I	Active
Zimmer® Natural Nail® System	47-2493-443-10	FDA UDI	Class II	Active
NexGen®	5988-11-18	FDA UDI	Class II	Active
NexGen®	5989-03-33	FDA UDI	Class II	Active
Persona® The Personalized Knee System	00-5907-080-64	FDA UDI	Class II	Active
Zimmer Persona Knee System	SSI004330	FDA UDI	Class II	Active
Ankle Fracture	SSI004208A0	FDA UDI	Class I	Active
mymobility® Platform	MMCWE001	FDA UDI	Class I	Active
Identity Humeral	110047178	FDA UDI	Class II	Active
Instrument Case 2	2800-90	FDA UDI	Class I	Active
NexGen®	5881-30-14	FDA UDI	Class I	Active
Wagner SL Revision®	01.00102.623	FDA UDI	Class II	Active
Natural-Knee®	6216-00-020	FDA UDI	Class II	Active
Curette	75.13.89	FDA UDI	Class I	Active
NexGen® Legacy®	5996-04-17	FDA UDI	Class II	Active

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