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
Otis-C Plus	Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 30 round head	FDA UDI	Class II	Unknown
Neotis	NEOTIS 50	FDA UDI	Class II	Unknown
Ligafix	Super elastic guide pin X5	FDA UDI	Class I	Active
Biosorb	BIO1 Granules	FDA UDI	Class II	Unknown
Rigidloop	BTB Adjustable Cortical System - XL	FDA UDI	Class II	Active
ComposiTCP	ComposiTCP 30 flat head	FDA UDI	Class II	Active
Fixit	FIXIT Knotless threaded anchor	FDA UDI	Class II	Active
Otis-F	AO Ø 4.5 mm tap	FDA UDI	Class I	Active
Ligafix	LIGAFIX guide pin sleeve for evolution femoral outside-in aiming device	FDA UDI	Class I	Active
Otis	one-piece metallic trial implant	FDA UDI	Class I	Active
ecoFIX	ecoFIX® Ø 4.5 mm Threaded Double-Loaded Suture Anchor System	FDA UDI	Class II	Active
Otis-C-Plus	Drill bit	FDA UDI	Class I	Active
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
RIGIDLOOP BTB Adjustable Cortical Button	NON STERILE SAMPLE - NOT FOR IMPLANTATION	FDA UDI	Class II	Active
Ligafix	LIGAFIX 60 round head	FDA UDI	Class II	Active
ComposiTCP	ComposiTCP 60 flat head	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 60 round head	FDA UDI	Class II	Active
Rigidloop	Clip Cortical Button - XL	FDA UDI	Class II	Active
Otis-C-Plus	Hexagonal screwdriver	FDA UDI	Class I	Active
ComposiTCP	ComposiTCP 60 round head	FDA UDI	Class II	Unknown
Biosorb	OTIS	FDA UDI	Class II	Unknown
Ligafix	Guide pin introducer for rigid guide pin Ø 0.9 mm	FDA UDI	Class I	Active
ecoFIX Band	ecoFIX® Band Ø 4.5 mm Threaded Double-Loaded Flat Suture Anchor	FDA UDI	Class II	Active
Fixit	Threaded anchor with tape mounted on screwdriver	FDA UDI	Class II	Active
Neotis	NEOTIS 50	FDA UDI	Class II	Unknown
Bio1-Kit	BIO1-KIT pre-loaded syringe with 4x4x4mm cubes	FDA UDI	Class II	Unknown
Fixit	FIXIT Knotless threaded anchor	FDA UDI	Class II	Active
ComposiTCP	ComposiTCP 60 round head	FDA UDI	Class II	Unknown
Otis-C Plus	NON STERILE OTIS-C PLUS Left Plate	FDA UDI	Class II	Unknown
Otis-F	Complete OTIS-F tray	FDA UDI	Class I	Active
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
Otis-C Plus	Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
MBlock	Adjustable Loop BTB	FDA UDI	Class II	Active
Rigidloop	Clip Cortical Button - Standard	FDA UDI	Class II	Active
Ligafix	Super elastic guide pin X5	FDA UDI	Class I	Active
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
Otis-C Plus	NON STERILE Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
Ligafix	Router bit	FDA UDI	Class I	Active
MBlock	Adjustable Loop	FDA UDI	Class II	Active
Otis	metallic trial implant	FDA UDI	Class I	Active
Biosorb	BIO1 Block	FDA UDI	Class II	Unknown
Fixit	Threaded anchor with tape mounted on screwdriver	FDA UDI	Class II	Active
Ligafix	LIGAFIX ratchet screwdriver rod Diameter 7-8 mm	FDA UDI	Class I	Active
Otis-C Plus	Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
Pullup	Adjustable juxtacortical fixation device for cortical tunnel = Ø 5 to 10 mm	FDA UDI	Class II	Unknown
Biosorb	OTIS	FDA UDI	Class II	Unknown
Otis-C Plus	NON STERILE Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
Biosorb	OTIS	FDA UDI	Class II	Unknown

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