Question 1

What types of medical devices does Joline GmbH & Co. KG manufacture?

Accepted Answer

Joline GmbH & Co. KG specializes in orthopaedic instruments and devices primarily used for spinal procedures. Their portfolio includes balloon kyphoplasty kits, bone access cannulas, kyphoplasty balloon catheters, orthopaedic cement dispensers, bone grafting cannulas, single-use syringes, manual cement mixers, and orthopaedic guidewires. These devices are designed for vertebral augmentation, bone preparation, and cement delivery in procedures like kyphoplasty.

Question 2

Where is Joline GmbH & Co. KG based, and what does that mean for their regulatory compliance?

Accepted Answer

Joline GmbH & Co. KG is based in the United States, which means their devices must comply with U.S. medical device regulations, including classification under the FDA’s regulatory framework. Since their products fall under Class I and Class II categories, they are subject to specific FDA requirements depending on their risk level and intended use.

Question 3

Which regulatory registries list Joline GmbH & Co. KG’s devices?

Accepted Answer

Joline GmbH & Co. KG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of their products under U.S. regulatory oversight, allowing healthcare providers and authorities to verify device details such as manufacturer information, model names, and classification.

Question 4

How are Joline GmbH & Co. KG’s devices classified under FDA regulations?

Accepted Answer

Joline GmbH & Co. KG’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

Question 5

What kinds of orthopaedic procedures are Joline GmbH & Co. KG’s devices intended for?

Accepted Answer

Joline GmbH & Co. KG’s devices are designed for spinal and orthopaedic procedures, particularly those involving vertebral augmentation. Their products like balloon kyphoplasty kits, bone access cannulas, and cement dispensers are used in procedures such as kyphoplasty, where bone cement is injected into fractured vertebrae to restore height and stability. Other tools, like guidewires and introducer cannulas, assist in precise bone preparation and access.

Device	Model / Reference	Registries	Class	Status
Best Kit SpeedTrack Stop'n GO 2 x 8 mm	US7HS2200	FDA UDI	Class II	Active
SpeedTrack Short Tip Introducer Cannula & Stylet	US9312	FDA UDI	Class II	Active
Smart Kit Modular OnePedicle 16/16	US7NN1110	FDA UDI	Class II	Active
Smart Kit Modular OnePedicle 22/16	US7NN1120	FDA UDI	Class II	Active
Smart Kit Stop'n GO 2 x 8 mm	US7NA2200	FDA UDI	Class II	Active
RapidIntro Bevel Tip Introducer Cannula & Stylet	US9213	FDA UDI	Class II	Active
Vertebra Filler Device (Frontal Opening)	US9601	FDA UDI	Class II	Active
Guide Pin, Blunt	US9102	FDA UDI	Class II	Active
Vertebra Introducer Device Introducer Cannula & Styet	US9201	FDA UDI	Class II	Active
Best Kit 16/16	US7HA2110	FDA UDI	Class II	Active
Vertebra Access Device wth Trocar Tip Access Needle	US9101	FDA UDI	Class II	Active
Access Kit	US7ZA0000	FDA UDI	Class II	Active
Vertebra Filler Device (Side Opening)	US9602	FDA UDI	Class II	Active
Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm	US7HN1200	FDA UDI	Class II	Active
Vertebra Biopsy Device Needle & Plunger	US9301	FDA UDI	Class II	Active
Filler Kit	US7ZN0000	FDA UDI	Class II	Active
Smart Kit Mod. One Pedicle Stop'n GO 2 x 8 mm	US7NN1200	FDA UDI	Class II	Active
Smart Kit OnePedicle 16/16	US7NA1110	FDA UDI	Class II	Active
Introducer Cannula Plug	US9203	FDA UDI	Class II	Active
Balloon Adapter	US9520	FDA UDI	Class II	Active
Smart Kit RapidIntro Bevel Tip 22/16	US7NR2120	FDA UDI	Class II	Active
Smart Kit 16/16	US7NA2110	FDA UDI	Class II	Active
Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm	US7HR2200	FDA UDI	Class II	Active
Allevo Curette	US9410	FDA UDI	Class II	Active
Best Kit 22/16	US7HA2120	FDA UDI	Class II	Active
Smart Kit 22/16	US7NA2120	FDA UDI	Class II	Active
Best Kit Stop'n GO 2 x 8 mm	US7HA2200	FDA UDI	Class II	Active
Vertebra Introducer Working Cannula	US9202	FDA UDI	Class II	Active
Best Kit 22/16	US7OA2120	FDA UDI	Class II	Active
Smart Kit SpeedTrack Stop'n GO 2 x 8 mm	US7NS2200	FDA UDI	Class II	Active
Kypho Balloon Catheter 22/16	US9403	FDA UDI	Class II	Active
Best Kit SpeedTrack Stop'n GO 2 x 8 mm	US7OS2200	FDA UDI	Class II	Active
Mixer	US9610	FDA UDI	Class I	Active
Vertebra Access Device with Bevel Tip Needle & Stylet	US9104	FDA UDI	Class II	Active
Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm	US7OR2200	FDA UDI	Class II	Active
Best Kit 16/16	US7OA2110	FDA UDI	Class II	Active
Smart Kit RapidIntro Bevel Tip 16/16	US7NR2110	FDA UDI	Class II	Active
Smart Kit OnePedicle 22/16	US7NA1120	FDA UDI	Class II	Active
Vacuum Syringe 20 ML	US9503	FDA UDI	Class II	Active
Stop'n GO Double Balloon Catheter	US9420	FDA UDI	Class II	Active
Best Kit Stop'n GO 2 x 8 mm	US7OA2200	FDA UDI	Class II	Active
Smart Kit SpeedTrack 16/16	US7NS2110	FDA UDI	Class II	Active
RapidIntro Trocar Tip Introducer Cannula & Stylet	US9211	FDA UDI	Class II	Active
Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm	US7ON1200	FDA UDI	Class II	Active
Smart Kit SpeedTrack 22/16	US7NS2120	FDA UDI	Class II	Active
Smart Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm	US7NR2200	FDA UDI	Class II	Active
Vertebra Filler Device Flex Plunger (Frontal Opening)	US9604	FDA UDI	Class II	Active
Bone Drill	US9302	FDA UDI	Class II	Active
Kypho Balloon Catheter 16/16	US9402	FDA UDI	Class II	Active
Filler Kit Flex	US7ZN000F	FDA UDI	Class II	Active

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