BETA
Italian manufacturer of minimally invasive devices for spine procedures, biopsy, tissue harvesting, assisted reproduction and related specialties.
BPB Medica is the medical-device brand of Biopsybell S.r.l., based in Mirandola, Modena, Italy. Founded in 1999, the company designs, manufactures and markets devices for minimally invasive procedures. Its company history records acquisition by the Bpunto3/Wallaby group in 2022.
The portfolio spans DISKOM percutaneous discectomy, RENOVA SPINE kyphoplasty, biopsy and bone marrow aspiration devices, adipose-tissue processing, assisted reproduction, aesthetic surgery and intensive-care consumables. The manufacturer reports distribution in more than 80 countries; product availability and regulatory status vary by market.
Solution Medical publicly identifies itself as a U.S. distributor for DISKOM, including cervical and thoracolumbar versions. This is distributor-reported evidence: manufacturer confirmation, exclusivity and current contractual authorization have not been independently established.
Five FDA 510(k) decisions are linked to selected current families: DISKOM (K180315; March 26, 2018), Renova Spine Balloon Catheter (K231340; October 30, 2023), bone marrow aspiration kits (K203397; January 11, 2021), and biopsy needles (K130616 and K010735). DISKOM’s cleared use covers aspiration of disc material during lumbar, thoracic and cervical percutaneous discectomies. [20][21][22][23]
K203397 covers bone marrow aspiration/explant through a piston syringe; it does not establish approval of a stem-cell therapy. Current-model U.S. authorization for adipose-processing, fertility, aesthetic and airway products has not been established. Two 2001 decisions, EASYBELL (K011075) and OSTEOBELL (K011104), are retained as unresolved historical mappings and excluded from the current count. [22]
FDA recall event 87696, initiated March 22, 2021, covers specified biopsy, kyphoplasty and cement-delivery products distributed as sterile that may not have been sterilized. The reviewed records contain 19 product recall entries within this single event, all marked terminated on February 17, 2026. These findings do not identify DISKOM as affected. No additional matching event was identified in the searches performed; broader model/OEM coverage remains incomplete. [24][25][26][27]
Latest recorded source review: 2026-10-22.
Documented commercial product families.
Single-use, motor-driven mechanical system for aspiration of disc material during percutaneous discectomy. The catalog lists thoracolumbar and cervical versions; the device uses a screw mechanism rather than laser or radiofrequency. [9][10][19][20]
FDA-clearedListed in the manufacturer’s current catalog; availability varies by market.
Balloon kyphoplasty family with 8G, 11G and 13G kits in the catalog. FDA K231340 covers the Renova Spine Balloon Catheter; clearance scope should be checked against the specific model and labeling. [3][14][21]
FDA-clearedListed in the manufacturer’s current catalog; availability varies by market.
VERTEBROSTEEL and VERTEBROPLASTIC needles, CEMIX cement mixer, EASYNJECT delivery system, bone-access and vertebral-biopsy tools, SCREWFIX and SPINOS bone cement are listed in the spine catalog. The representative image depicts CEMIX. [3]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
Includes SPEEDYBELL semi-automatic needles, ESTER automatic biopsy devices, BIOSOFT, OSTEOBELL T and OSTEOBELL EXPLANT, STERNOBELL, ILIAC MARROW, FULLY REMOVE, TOTALLY REMOVE, UNLUX, CHIBELL and GAMMA. The representative image depicts SPEEDYBELL. [4][16][17][23]
FDA-clearedListed in the manufacturer’s current catalog; availability varies by market.
Bone marrow aspiration devices; K203397 names Marrow-Pack, Marrow-Tray, Marrow-Set, Marrow-kit and Marrow-Stem configurations. Its cleared use is aspiration/explant of bone marrow through a piston syringe, rather than approval of a stem-cell therapy. [5][15][22]
FDA-clearedListed in the manufacturer’s current catalog; availability varies by market.
Closed-circuit adipose-tissue microfragmentation and purification kits listed in the ortho-biologics and spine catalogs. A matched U.S. authorization for these specific current models was not established. [5]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
ORTHOPLASTY is a subchondral bone-plasty kit; OSTEOPLASTY is a balloon-based metaphyseal fracture treatment kit. The representative image shows ORTHOPLASTY. U.S. model-specific authorization remains unresolved. [5]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
KINDER DL and KINDER PLUS oocyte aspiration needles; AINSE insemination and TRANSFER embryo-transfer catheters; SUPERVITRI vitrification carriers; CHIBELL, GAMMA, SET VILLOCENTESI and VA-CVS prenatal diagnostic devices. Representative image: KINDER DL. [6]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
Adipose-tissue purification and microfragmentation kits marketed for lipofilling and reconstructive/aesthetic procedures. U.S. model-specific authorization was not established. [7]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
Heat and moisture exchanger for tracheostomized patients, with an oxygen port and bidirectional valve. U.S. model-specific authorization was not established. [8]
Marketed · regulatory scope variesListed in the manufacturer’s current catalog; availability varies by market.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Solution Medical (distributor-reported) [11][12] | United States (distributor-reported; contractual territory unconfirmed) | DISKOM — cervical and thoracolumbar versions |
Sources checked October 22, 2026.
Accessed 10/22/2026
Last substantive review: 10/22/2026