Question 1

What types of medical devices does S.B.M manufacture?

Accepted Answer

S.B.M manufactures a range of orthopaedic and sports medicine devices, including bioabsorbable and non-bioabsorbable orthopaedic bone screws and tendon/ligament anchors. They also produce reusable arthroscopic surgical tools like drill bits, guidewires, and depth gauges, as well as synthetic bone graft materials and reusable arthroscopic procedure kits. Their portfolio further includes specialized fixation systems, such as knotless tendon/ligament anchors, designed for specific surgical applications.

Question 2

Where is S.B.M based, and what regulatory jurisdiction does it operate under?

Accepted Answer

S.B.M is based in the United States. As a manufacturer operating within this jurisdiction, the company adheres to the regulatory requirements set forth by the FDA for medical devices. This includes compliance with applicable standards and guidelines to ensure the safety and performance of its products.

Question 3

Which regulatory registries or databases list S.B.M’s devices?

Accepted Answer

S.B.M’s devices are listed in the FDA’s Unique Device Identification (UDI) system. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory and healthcare environments. This listing helps track and manage devices throughout their lifecycle.

Question 4

How are S.B.M’s devices classified by the FDA?

Accepted Answer

S.B.M’s devices are classified under FDA Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential risks, and the duration of contact with the body, as outlined in FDA regulations.

Question 5

What distinguishes S.B.M’s reusable arthroscopic surgical tools from their disposable counterparts?

Accepted Answer

S.B.M manufactures reusable arthroscopic surgical tools like cannulated drill bits, guidewires, and depth gauges, which are designed to withstand multiple sterilization cycles while maintaining performance. These tools are engineered for durability and precision, reducing waste compared to disposable alternatives. Reusability also aligns with cost-efficiency and sustainability goals in surgical settings, though they must meet stringent regulatory standards for reprocessing and safety.

Device	Model / Reference	Registries	Class	Status
Bio1-Kit	BIO1-KIT pre-loaded syringe with 4x4x4mm cubes	FDA UDI	Class II	Unknown
Neotis	NEOTIS	FDA UDI	Class II	Unknown
Biosorb - Bio1-S	BIO1-S with Ø 0.6 mm granules	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
Ligafix	Drill bit	FDA UDI	Class I	Active
Biosorb	BIO1 Macroporous	FDA UDI	Class II	Unknown
Sbm	Drill bit Ø 4 mm - length 450 mm	FDA UDI	Class I	Active
Rigidloop	Suture Loop	FDA UDI	Class II	Active
Biosorb	OTIS 50	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
ecoFIX Knotless	ecoFIX® Knotless Ø 4.5 mm Threaded Anchor	FDA UDI	Class II	Active
Otis	Screwdriver for OTIS screw extraction	FDA UDI	Class I	Active
Ligafix	LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, longflute	FDA UDI	Class I	Active
FIXIT & ecoFIX	Punch Tap - 5.5 mm and 6.5 mm	FDA UDI	Class I	Active
Fixit	Threaded anchor mounted on screwdriver	FDA UDI	Class II	Active
Biosorb	BIO1 Stick	FDA UDI	Class II	Unknown
FIXIT / ecoFIX	Suture passer automatic grasper - Shoulder	FDA UDI	Class I	Active
Otis-C Plus	Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
Biosorb	BIO1 Granules	FDA UDI	Class II	Unknown
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
Fixit	Complete FIXIT basket 1st + 2nd rows with automatic grasper	FDA UDI	Class I	Unknown
MENIX / FIXIT / ecoFIX	Non sterile needle (x10)	FDA UDI	Class I	Active
Fixit	Complete FIXIT basket 1st + 2nd rows	FDA UDI	Class I	Active
Neotis	NEOTIS 50 XS	FDA UDI	Class II	Unknown
Neotis	NEOTIS	FDA UDI	Class II	Unknown
Bio1-Kit	BIO1-KIT pre-loaded syringe with Ø3 mm granules	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX 60 round head	FDA UDI	Class II	Active
Biosorb	OTIS	FDA UDI	Class II	Unknown
Otis	metallic trial implant	FDA UDI	Class I	Active
FIXIT & ecoFIX	Cleaning and sterilization basket	FDA UDI	Class I	Active
MENIX / FIXIT / ecoFIX	Non sterile needle (x1)	FDA UDI	Class I	Active
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
Sbm	250 x 250 sterilization basket lid	FDA UDI	Class I	Active
Otis	metallic trial implant	FDA UDI	Class I	Active
ComposiTCP	ComposiTCP 30 round head	FDA UDI	Class II	Unknown
Biosorb - Bio1-S	BIO1-S with Ø 1.5 mm granules	FDA UDI	Class II	Unknown
Bio1-Kit	BIO1-KIT pre-loaded syringe with Ø1.5 mm granules	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 60 flat head	FDA UDI	Class II	Active
Pullup	Adjustable juxtacortical fixation device for cortical tunnel = Ø 4.5 mm	FDA UDI	Class II	Unknown
Pullup-Ligafix	PULLUP-LIGAFIX complete ligamentoplasty instrumentation set	FDA UDI	Class I	Active
Fixit	Complete FIXIT basket 1st row with automatic grasper	FDA UDI	Class I	Unknown
ComposiTCP™	Double loaded MaxBraid suture anchor	FDA UDI	Class II	Active
Biosorb	BIO1 Granules	FDA UDI	Class II	Unknown
Otis	metallic trial implant	FDA UDI	Class I	Active
Otis	Cleaning and sterilization basket	FDA UDI	Class I	Active
Ligafix	Router bit	FDA UDI	Class I	Active
ComposiTCP	ComposiTCP 30 round head	FDA UDI	Class II	Active
Otis	metallic trial implant	FDA UDI	Class I	Active
Ligafix	Rigid guide pin X10	FDA UDI	Class I	Active
MBlock	Adjustable Loop XL	FDA UDI	Class II	Active

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