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
Ligafix	LIGAFIX ratchet tap rod Diameter 7-8 mm	FDA UDI	Class I	Active
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
Fixit	FIXIT Threaded anchor system	FDA UDI	Class II	Unknown
RetroTech	Ring for RetroTech® retrograde drill	FDA UDI	Class I	Active
Ligafix	LIGAFIX 60 round head	FDA UDI	Class II	Active
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
Biosorb	BIO1 Cubes	FDA UDI	Class II	Unknown
Biosorb	BIO1 Stick	FDA UDI	Class II	Active
Otis-C Plus	NON STERILE Screw for OTIS-C PLUS plate fixation	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 30 flat head	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Active
ComposiTCP	ComposiTCP 60 round head	FDA UDI	Class II	Unknown
Ligafix	LIGAFIX Graft gauge - half sizes	FDA UDI	Class I	Active
Biosorb - Bio1-S	BIO1-S with Ø 1 mm granules	FDA UDI	Class II	Unknown
Biosorb	OTIS 50	FDA UDI	Class II	Unknown
Biosorb	BIO1 Granules	FDA UDI	Class II	Active
Ligafix	Drill bit	FDA UDI	Class I	Active
MENIX / FIXIT / ecoFIX	Non sterile needle (x5)	FDA UDI	Class I	Active
ComposiTCP	ComposiTCP 30 flat head	FDA UDI	Class II	Active
Biosorb	BIO1 Stick	FDA UDI	Class II	Active
Fixit	FIXIT Knotless threaded anchor	FDA UDI	Class II	Active
Ligafix	Router bit	FDA UDI	Class I	Active
GraftTech	Graft preparation station	FDA UDI	Class I	Active
Fixit	Threaded anchor with tape mounted on screwdriver	FDA UDI	Class II	Active
Ligafix	Super elastic guide pin X5	FDA UDI	Class I	Active
ecoFIX	Screwdriver	FDA UDI	Class I	Active
Biosorb - Bio1-S	BIO1-S with Ø 0.6 mm granules	FDA UDI	Class II	Unknown
Otis-C Plus	NON STERILE OTIS-C PLUS Right Plate	FDA UDI	Class II	Unknown
ComposiTCP™	Non-sliding BroadBand	FDA UDI	Class II	Active
Ligafix	LIGAFIX ratchet screwdriver rod Diameter 9-10-11 mm	FDA UDI	Class I	Active
Ligafix	LIGAFIX 30 round head	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 60 round head	FDA UDI	Class II	Unknown
ecoFIX	ecoFIX® Ø 6.5 mm Threaded Double-Loaded Suture Anchor System	FDA UDI	Class II	Active
Neotis	NEOTIS 50	FDA UDI	Class II	Unknown
ComposiTCP	ComposiTCP 30 flat head	FDA UDI	Class II	Active
Ligafix	Super elastic guide pin X1	FDA UDI	Class I	Active
Ligafix	LIGAFIX complete Outside-In instrumentation set -	FDA UDI	Class I	Active
Otis-C Plus	OTIS-C PLUS Plate - Right	FDA UDI	Class II	Unknown
Ligafix	Router bit	FDA UDI	Class I	Active
Biosorb - Bio1-S	BIO1-S with Ø 0.6 mm granules	FDA UDI	Class II	Unknown
RetroTech	Cleaning and sterilization basket	FDA UDI	Class I	Active
Ligafix	Super elastic guide pin X10	FDA UDI	Class I	Active
Biosorb	OTIS 50	FDA UDI	Class II	Unknown
Otis	OTIS complete instrumentation set for HTO	FDA UDI	Class I	Active
Biosorb	OTIS 50	FDA UDI	Class II	Unknown
Ligafix	Router bit	FDA UDI	Class I	Active
Ligafix	Super elastic guide pin X10	FDA UDI	Class I	Active
Neotis	NEOTIS	FDA UDI	Class II	Unknown
MBlock	Adjustable Loop	FDA UDI	Class II	Active

S.B.M

What S.B.M makes

Frequently asked questions

Information

Catalogue (438)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities