Cerament G

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) DEN210044

by Bonesupport AB

Identity

Trade Name: CERAMENT® G FDA UDI
Generic Name: Bone matrix implant, synthetic, antimicrobial FDA UDI
Device Name: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads. FDA UDI
Model / Reference: A0450-10 FDA UDI
Description: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads. FDA UDI

Identifiers

Primary DI / UDI-DI: 07350055430387 FDA UDI
510(k) Number: DEN210044 FDA 510(k)FDA UDI
FDA Product Code: QRR FDA 510(k)FDA UDI
GMDN Term: Bone matrix implant, synthetic, antimicrobial FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 888.3046 FDA 510(k)
Regulation Number: 888.3046 FDA 510(k)FDA UDI
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: DENG FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Total Volume — 10 Milliliter FDA UDI

Cerament G is a Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside, classified as a Class II medical device. It is an injectable, resorbable bioceramic composed of 40% hydroxyapatite and 60% calcium sulfate, with the addition of gentamicin sulfate for antimicrobial properties. Designed to support bone regeneration, it provides osteoconductive scaffolding while gradually resorbing in sync with new bone formation.

This device is supplied as a sterile, single-use injectable paste for orthopedic applications in bone defect sites at risk of infection. It is intended for use in MRI-compatible settings, with no contraindications related to magnetic fields. Packaged in pre-filled syringes, it requires refrigerated storage and is regulated under FDA 510(k) clearance (K210044). Authorisations include FEI numbers 3005304945, 3003870583, and 3010413864 under regulation 888.3046.

Frequently asked questions

What is the primary purpose of Cerament G in orthopedic procedures and how does its composition support bone healing?

Cerament G is designed to support bone regeneration by providing an osteoconductive scaffold at bone defect sites, particularly those at risk of infection. Its composition—40% hydroxyapatite and 60% calcium sulfate—gradually resorbs in sync with new bone formation, while the added gentamicin sulfate offers antimicrobial properties to help prevent infection during healing.

How is Cerament G supplied and what storage conditions are required to maintain its sterility?

Cerament G is supplied as a sterile, single-use injectable paste in pre-filled syringes, ensuring ease of use in orthopedic procedures. To preserve sterility, it must be stored refrigerated, as specified by the manufacturer.

Can Cerament G be used in MRI settings, and if so, why is this important for clinicians?

Yes, Cerament G is explicitly designed for use in MRI-compatible settings, meaning it does not contain materials that would interfere with magnetic resonance imaging. This is important for clinicians because it allows for post-operative imaging without the risk of artifacts or safety concerns, facilitating ongoing monitoring of bone healing.

Is Cerament G reusable, or is it intended for one-time use per patient?

Cerament G is intended for single-use only per patient, as indicated by its packaging as a sterile, pre-filled syringe. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cerament® G - Bonesupport, Home - BONESUPPORT, CERAMENT® - Bonesupport, PDF BoneSupport AB Blerta Shuka Sr. Regulatory Affairs Specialist ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	DEN210044	Class II	Active

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Manufacturer

Manufacturer: Bonesupport AB

Sources (2)

FDA 510(k) DEN210044 24 fields · synced Oct 6, 2026
FDA UDI bae66df1-4ba2-4113-9b16-e98adb4a1a7c 37 fields · synced May 27, 2026