Question 1

What types of medical devices does Maxx Orthopedics Inc. manufacture?

Accepted Answer

Maxx Orthopedics Inc. specializes in orthopedic implants used primarily for knee and hip replacements. Their product line includes uncoated and coated knee tibia and femur prostheses (both metallic and polyethylene), non-constrained polyethylene acetabular liners, tibial inserts, and modular hip femur prostheses. These devices are designed to restore joint function in patients undergoing total joint arthroplasty.

Question 2

Where is Maxx Orthopedics Inc. based?

Accepted Answer

Maxx Orthopedics Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing standards, and compliance with U.S. medical device regulations.

Question 3

Which regulatory registries or databases list Maxx Orthopedics Inc.’s devices?

Accepted Answer

Maxx Orthopedics Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device details and compliance.

Question 4

How are Maxx Orthopedics Inc.’s devices classified under FDA regulations?

Accepted Answer

All of Maxx Orthopedics Inc.’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls (beyond general controls) to ensure safety and effectiveness, such as orthopedic implants that require performance standards or post-market surveillance.

Question 5

What distinguishes Maxx Orthopedics Inc.’s orthopedic implants from other manufacturers?

Accepted Answer

Maxx Orthopedics Inc. focuses on a range of modular and press-fit orthopedic implants, including both knee and hip replacements, with variations like uncoated/metallic polyethylene components and modular hip stems. Their devices are designed for durability and compatibility in total joint arthroplasty, with a consistent classification as Class II, indicating they undergo rigorous evaluation for structural integrity and clinical performance.

Device	Model / Reference	Registries	Class	Status
Freedom Knee Cementless	PFCRRB00-PK	FDA UDI	Class II	Active
Freedom Partial Knee	313470	FDA UDI	Class II	Active
Freedom Partial Knee	311368	FDA UDI	Class II	Active
Freedom Partial Knee	313420	FDA UDI	Class II	Active
Freedom Knee Cementless	PFCRLG00-PK	FDA UDI	Class II	Active
Freedom Partial Knee	314500	FDA UDI	Class II	Active
Freedom Knee Cementless	PFPSRA00-PK	FDA UDI	Class II	Active
Freedom(R) - TiNbN Coated Knee	K200912	FDA 510(k)	Class II	Active
Maxx Libertas Bipolar Hip Head (Bipolar Hip)	K243634	FDA 510(k)	Class II	Active
Freedom Total Knee Cruciate Retaining (cr) Femoral Component	K091280	FDA 510(k)	Class II	Active
Freedom(r) Stemmed Tibial Components	K111785	FDA 510(k)	Class II	Active
Freedom Primary PCK	K192148	FDA 510(k)	Class II	Active
Freedom Cementless Femoral Component	K150680	FDA 510(k)	Class II	Active
Freedom® Total Knee System – Titan PCK Components	K253144	FDA 510(k)	Class II	Active
Freedom® Total Knee System – Titanium Tibial Base Plate	K251717	FDA 510(k)	Class II	Active
Freedom Total Knee System	K082019	FDA 510(k)	Class II	Active
Libertas Acetabular Hooded Liner	K183365	FDA 510(k)	Class II	Active
Freedom® Total Knee System - Porous Tibial Base Plate	K241597	FDA 510(k)	Class II	Active
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)	K253171	FDA 510(k)	Class II	Active
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)	K252777	FDA 510(k)	Class II	Active
Freedom Metal Backed Tibial Component	K090411	FDA 510(k)	Class II	Active
Libertas Hip Replacement System	K180973	FDA 510(k)	Class II	Active
Freedom® Medial Congruent Liner	K243277	FDA 510(k)	Class II	Active
Freedom Total Knee System (All-poly Tibial Plate)	K250382	FDA 510(k)	Class II	Active
Freedom® Total Knee System	K240863	FDA 510(k)	Class II	Active
Freedom Pck Components	K131481	FDA 510(k)	Class II	Active
Freedom Infinia™ Total Knee System	K253314	FDA 510(k)	Class II	Active
Libertas – Taper Uncemented Femoral Stem	K183684	FDA 510(k)	Class II	Active
Libertas E-XLPE Modular Liner	K192989	FDA 510(k)	Class II	Active
Freedom Ultra-Congruent CR Tibial Liner	K182574	FDA 510(k)	Class II	Active

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