BETA
German manufacturer of kyphoplasty systems, dialysis catheters and cardiac biopsy instruments, with stent and OEM manufacturing services.
Joline GmbH & Co. KG is a medical-device manufacturer headquartered in Hechingen, Germany. Founded in 1999, it develops and manufactures minimally invasive products across dialysis, spine and cardiology, alongside contract manufacturing of stents, implants and medical components.
The portfolio includes short- and long-term dialysis catheters, kyphoplasty balloon catheters and procedural instruments, and KNIPSA endomyocardial biopsy forceps. Product availability and regulatory scope vary by market; the U.S. website specifically presents the kyphoplasty portfolio.
Christian Keller leads the German manufacturer as CEO. Its U.S. subsidiary, Joline Medical Inc. in Clearwater, Florida, distributes the spine portfolio in North America. Sammy Silva is identified by the parent company as the subsidiary’s Vice President of Sales & Marketing; that regional role is distinct from parent-company leadership.
FDA 510(k) K192449 cleared the Joline Kyphoplasty System Allevo on May 27, 2020. The cleared system includes single- and double-balloon options and instruments for fracture reduction/fixation or creation of a void in cancellous spinal bone during balloon kyphoplasty, for use with cleared spinal PMMA bone cement. This is a 510(k) clearance, rather than a PMA approval. [8][5]
The wider German catalog includes dialysis catheters and KNIPSA cardiac biopsy forceps. An older FDA record, K063355, documents Joline D-Line short-term dialysis catheters submitted by NovoSci in 2007. Its connection to current models and U.S. availability has not been established, so it is excluded from the current-portfolio clearance count. The kyphoplasty clearance does not cover the other divisions. [15][14][6]
No matching Joline recall event was identified in the company/product-name or linked-identifier searches reviewed. Two NovoSci recalls concerned unrelated products and were excluded. Current product linkage across the global and OEM portfolio remains incomplete, so missing totals should not be read as zero. [9]
Latest recorded source review: 2026-10-22.
Documented commercial product families.
Single- and double-balloon catheters with bone-access, inflation and cement-application instruments for balloon kyphoplasty. [17][19][5]
FDA-clearedKyphoplasty products marketed in the U.S. by Joline Medical Inc.; configurations vary by market.
Short- and long-term catheter families, including high-flow, pediatric and tunneled configurations for extracorporeal blood purification. [15][6]
Marketed · regulatory scope variesListed in the global catalog; current U.S. availability is not established.
KNIPSA500 and KNIPSA1100 forceps for collection of endomyocardial tissue through jugular or femoral access, respectively. [14]
Marketed · regulatory scope variesListed in the German/global catalog; U.S. authorization and availability not established.
Joline also offers stent and implant contract manufacturing, prototyping, product development and medical injection molding. These services are described separately from the own-branded product families and do not establish U.S. authorization for customer devices. [13]
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Joline Medical Inc. (U.S. subsidiary) [12][21] | North America | Joline spine / kyphoplasty portfolio |
Sources checked October 22, 2026.
Accessed 10/22/2026