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
XtraFix®	00-5214-030-20	FDA UDI	Class II	Active
VerSys®	7895-26-02	FDA UDI	Class I	Active
Affixus®	815408380	FDA UDI	Class II	Active
NexGen® Legacy® Prolong®	5962-31-14	FDA UDI	Class II	Active
M/Dn®	2241-13-37	FDA UDI	Class I	Active
PERSONA® Vivacit-E®	42-5221-006-14	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5120-005-13	FDA UDI	Class II	Active
Zmr®	9981-240-33	FDA UDI	Class II	Active
Wagner Cone Prosthesis®	75.11.15-220	FDA UDI	Class II	Active
NexGen®	5971-16-02	FDA UDI	Class I	Active
NexGen® Legacy®	5995-51-17	FDA UDI	Class I	Active
ZCA® Longevity®	8065-554-28	FDA UDI	Class II	Active
Itst®	2257-180-14	FDA UDI	Class II	Active
NexGen® Legacy®	5996-11-02	FDA UDI	Class III	Active
Persona®	42-5606-135-15	FDA UDI	Class II	Active
Affixus®	815410390	FDA UDI	Class II	Active
Persona® Trabecular Metal®	42-5008-058-01	FDA UDI	Class II	Active
Ncb®	02.03158.055	FDA UDI	Class II	Active
Zimmer® Natural Nail® System	47-2493-182-13	FDA UDI	Class II	Active
NexGen® Legacy®	5964-31-20	FDA UDI	Class II	Active
Natural-Knee®	6207-12-010	FDA UDI	Class II	Active
NexGen®	5988-07-28	FDA UDI	Class II	Active
MultiPolar®	5001-60-22	FDA UDI	Class II	Active
M/Dn®	2254-195-06	FDA UDI	Class II	Active
M/Dn®	2253-280-11	FDA UDI	Class II	Active
Magna-FX®	1142-14	FDA UDI	Class I	Active
Persona®	42-5601-175-11	FDA UDI	Class II	Active
Trabecular Metal Reverse Plus™	00-4362-015-00	FDA UDI	Class II	Active
G7 Prov Neutral Liner	SSI006105	FDA UDI	Class I	Active
PERSONA™ Trabecular Metal™	42-5008-074-01	FDA UDI	Class II	Active
Natural-Knee®	6308-04-800	FDA UDI	Class I	Active
Trilogy®	6110-40-22	FDA UDI	Class II	Active
Natural-Knee®	6221-00-009	FDA UDI	Class II	Active
Persona® The Personalized Knee®	42-5274-009-10	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5220-007-13	FDA UDI	Class II	Active
PERSONA® Persona SoluTion™	42-5076-068-01	FDA UDI	Class II	Unknown
NexGen	82-0160-117-38	FDA UDI	Class I	Active
G7® Vivacit-E®	30154408	FDA UDI	Class II	Active
NexGen	SSI004637	FDA UDI	Class II	Active
Affixus® Natural Nail®	110035671	FDA UDI	Class II	Active
Continuum® Trilogy® Allofit®	00-8731-019-36	FDA UDI	Class II	Active
Prolong® NexGen®	5952-21-14	FDA UDI	Class II	Active
M/Dn®	2253-380-14	FDA UDI	Class II	Active
Nexel®	00-8401-036-02	FDA UDI	Class II	Active
Persona®	42-5000-050-01	FDA UDI	Class II	Active
PERSONA® Vivacit-E®	42-5120-001-14	FDA UDI	Class II	Active
NexGen®	5987-84	FDA UDI	Class I	Active
Zmr®	9932-16-35	FDA UDI	Class II	Active
Continuum® Trilogy® Allofit®	00-8735-007-28	FDA UDI	Class II	Active
Natural Nail®	47-2483-070-60	FDA UDI	Class II	Active

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