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Sign in to claim this brandS.B.M
US
Last updated May 24, 2026
What S.B.M makes
The company manufactures bioabsorbable and non-bioabsorbable orthopaedic bone screws and tendon/ligament anchors, reusable arthroscopic surgical tools including drill bits, guidewires, and depth gauges, as well as synthetic bone graft materials and reusable arthroscopic procedure kits. Their portfolio also includes knotless tendon/ligament fixation systems and specialized implants designed for orthopaedic and sports medicine applications.
The devices fall under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does S.B.M manufacture?
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.
Where is S.B.M based, and what regulatory jurisdiction does it operate under?
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.
Which regulatory registries or databases list S.B.M’s devices?
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.
How are S.B.M’s devices classified by the FDA?
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.
What distinguishes S.B.M’s reusable arthroscopic surgical tools from their disposable counterparts?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medacta.us.com
- —
- —
- [email protected]
- Phone
- 901-203-3470
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 772462123
Catalogue (438)
Page 5 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ecoFIX | ecoFIX® Ø 5.5 mm Threaded Double-Loaded Suture Anchor System | FDA UDI | Class II | Active |
| Bio1-Kit | BIO1-KIT pre-loaded syringe with 4x4x4mm cubes | FDA UDI | Class II | Unknown |
| ComposiTCP | ComposiTCP 60 round head | FDA UDI | Class II | Unknown |
| Biosorb | BIO1 Granules | FDA UDI | Class II | Unknown |
| Bio1-Kit | BIO1-KIT pre-loaded syringe with Ø3 mm granules | FDA UDI | Class II | Unknown |
| Biosorb - Bio1-S | BIO1-S with Ø 1 mm granules | FDA UDI | Class II | Unknown |
| Otis-C-Plus | Drill bit | FDA UDI | Class I | Active |
| Biosorb | BIO1 Cylinder | FDA UDI | Class II | Unknown |
| Menix Duo | Meniscal suture system, 2 anchors | FDA UDI | Class II | Active |
| ComposiTCP | ComposiTCP 60 flat head | FDA UDI | Class II | Unknown |
| Ligafix | LIGAFIX 30 round head | FDA UDI | Class II | Active |
| Ligafix | LIGAFIX 30 round head | FDA UDI | Class II | Active |
| Ligafix | LIGAFIX 30 round head | FDA UDI | Class II | Active |
| Biosorb | BIO1 Cubes | FDA UDI | Class II | Unknown |
| Neotis | NEOTIS | FDA UDI | Class II | Unknown |
| Ligafix | Non-cannulated drill bit | FDA UDI | Class I | Active |
| Ligafix | Router bit | FDA UDI | Class I | Active |
| Ligafix | SN-SBM open stripper | FDA UDI | Class I | Active |
| Ligafix | Router bit | FDA UDI | Class I | Active |
| Biosorb | BIO1 Granules | FDA UDI | Class II | Active |
| Otis-F | Handle for OTIS-F AO tap | FDA UDI | Class I | Active |
| RetroTech | Complete RetroTech instrumentation set | FDA UDI | Class I | Active |
| Otis-C Plus | NON STERILE Screw for OTIS-C PLUS plate fixation | FDA UDI | Class II | Unknown |
| Biosorb | BIO1 Block | FDA UDI | Class II | Unknown |
| Ligafix | LIGAFIX 60 round head | FDA UDI | Class II | Unknown |
| ComposiTCP | ComposiTCP 30 round head | FDA UDI | Class II | Active |
| Biosorb | OTIS 50 | FDA UDI | Class II | Unknown |
| ComposiTCP | Modular driver for ComposiTCP screws | FDA UDI | Class I | Active |
| Ligafix | Super elastic guide pin X10 | FDA UDI | Class I | Active |
| 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 |
| Otis | one-piece metallic trial implant | FDA UDI | Class I | Active |
| RetroTech | Ø 4.7 mm cannulated drill bit | FDA UDI | Class I | Active |
| Ligafix | Drill bit | FDA UDI | Class I | Active |
| Ligafix | LIGAFIX complete Blind Tunnel instrumentation set | FDA UDI | Class I | Active |
| Ligafix | LIGAFIX 30 round head | FDA UDI | Class II | Unknown |
| Neotis | NEOTIS Plate - Right | FDA UDI | Class II | Unknown |
| Pullup Tex Clip | Adjustable fixation system for ligament reconstruction – loop only | FDA UDI | Class II | Active |
| Neotis | NEOTIS | FDA UDI | Class II | Unknown |
| ecoFIX Needle | ecoFIX® Needle Ø 4.5 mm Threaded Double-Loaded Suture Anchor System | FDA UDI | Class II | Active |
| ComposiTCP™ | Double loaded MaxBraid suture anchor | FDA UDI | Class II | Active |
| Biosorb - Bio1-S | BIO1-S with Ø 0.6 mm granules | FDA UDI | Class II | Unknown |
| Ligafix | Rigid guide pin X5 | FDA UDI | Class I | Active |
| Biosorb | BIO1 Granules | FDA UDI | Class II | Unknown |
| Fixit | FIXIT Threaded anchor system | FDA UDI | Class II | Active |
| ComposiTCP | ComposiTCP 60 flat head | FDA UDI | Class II | Active |
| Otis-C-Plus | Cleaning and sterilization basket | FDA UDI | Class I | Active |
| Sbm | Complete set for extremity surgery | FDA UDI | Class I | Active |
| Biosorb | BIO1 Granules | FDA UDI | Class II | Unknown |
| Menix | MENIX Knot pusher | FDA UDI | Class I | Active |
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