Companies / BONESUPPORT

Medical device company profile

BONESUPPORT

Injectable bone-graft substitutes, including antibiotic-eluting CERAMENT products for bone repair.

Medical Device ManufacturerOrthopedics & MusculoskeletalBone Repair & ReconstructionCommercial-stage

Headquarters🇸🇪Lund, Sweden

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingUS$37 million ^[21]Equity and debt · Oct 2016

Official websitewww.bonesupport.com ↗

Company overview

BONESUPPORT is a Swedish orthobiologics company developing and commercializing injectable ceramic bone-graft substitutes. Its CERAMENT platform combines calcium sulfate and hydroxyapatite, with product variants incorporating gentamicin or vancomycin.

FDA granted CERAMENT G De Novo authorization in May 2022. CERAMENT V has a separate U.S. regulatory program: the company reported submitting an additional data package in September 2026, and U.S. authorization has not been established in this profile. Availability outside the U.S. follows local labeling.

CEO Torbjörn Sköld leads a business focused on surgeon education, clinical evidence and expansion of bone-infection and trauma applications. Product variants and country-specific indications are kept separate when interpreting regulatory milestones.

^{[10][11][12][13][14][21]}

Leadership

4 people

Torbjörn SköldChief Executive Officer ^[12]

Håkan JohanssonChief Financial Officer ^[12]

Annelie Aava ViknerEVP Global Marketing ^[12]

Mike RothGM & EVP Commercial Operations, US ^[12]

Products & regulatory status How does MedTechIndex get this information?

Summary

CERAMENT G has a De Novo grant and a subsequent 510(k) clearance; CERAMENT BONE VOID FILLER has a separate 510(k) history. CERAMENT V is sold in some non-U.S. markets, while its U.S. bone-infection application remains a separate De Novo submission. The company’s October 2026 disclosure says it submitted the requested additional data package; a U.S. grant was not identified in the published decisions reviewed. ^{[14][10][7][8][9][15]}

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. ^[17][18]

Regulatory snapshot How to read this snapshot

U.S. FDA

6
510(k) clearances: 1
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Antibiotic-eluting bone void filler

CERAMENT G ↗

Injectable bone-graft substitute containing gentamicin. ^[14][1]

FDA De Novo granted

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Bone graft substitute

CERAMENT BONE VOID FILLER ↗

Injectable calcium sulfate and hydroxyapatite bone-graft substitute. ^[14]

Marketed · regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Antibiotic-eluting bone void filler

CERAMENT V ↗

Vancomycin-containing CERAMENT variant; offered in selected non-U.S. markets. ^[14]

Marketed · regulatory scope varies

Marketed in selected non-U.S. markets; U.S. De Novo application pending in latest reviewed company update.

Commercial development

CERAMENT V U.S. application remains separate from the commercial CERAMENT G authorization. ^[14][10]

Activity & Milestones

1 events

2026-09-21 · Regulatory

Additional CERAMENT V data submitted

Company reported submitting an additional data package for the pending U.S. De Novo application. ^[10]

21 Cited Sources

Accessed 10/29/2026

[1] FDA De Novo DEN210044 ↗U.S. Food and Drug Administration · regulatory database

[2] FDA K234008 — CERAMENT G ↗U.S. Food and Drug Administration · regulatory record

[3] FDA K073316 — CERAMENT BONE VOID FILLER, MODEL A0210 ↗U.S. Food and Drug Administration · regulatory record

[4] FDA K090871 — CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 ↗U.S. Food and Drug Administration · regulatory record

[5] FDA K201535 — Cerament Bone Void Filler ↗U.S. Food and Drug Administration · regulatory record

[6] FDA DEN210044 — CERAMENT G ↗U.S. Food and Drug Administration · regulatory record

[7] FDA K051951 — CERAMENT BONE VOID FILLER ↗U.S. Food and Drug Administration · regulatory record

[8] FDA K240459 — Cerament Bone Void Filler ↗U.S. Food and Drug Administration · regulatory record

[9] Start | BONESUPPORT ↗BONESUPPORT · company website

[10] CERAMENT V De Novo update, September 2026 ↗BONESUPPORT · company website

[11] Employer hiring source reviewed ↗BONESUPPORT · company website

[12] Current leadership ↗BONESUPPORT · company website

[13] Active role: HR Director, US ↗BONESUPPORT · company website

[14] CERAMENT portfolio ↗BONESUPPORT · company website

[15] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[16] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[17] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[18] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[19] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[20] FDA De Novo database — research search ↗FDA / openFDA · regulatory record

[21] BONESUPPORT announces US$37 million equity and debt financing ↗BONESUPPORT · company announcement