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Cerament® G

FDA UDI

Class II (US FDA UDI)

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 CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. 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. In bone infection, CERAMENT G can also be inserted as pre-set beads. FDA UDI
Model / Reference
A0535-05 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 CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. 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. In bone infection, CERAMENT G can also be inserted as pre-set beads. FDA UDI

Identifiers

Primary DI / UDI-DI
07350055430523 FDA UDI
510(k) Number
DEN210044 FDA UDI
K234008 FDA UDI
FDA Product Code
QRR FDA UDI
GMDN Term
Bone matrix implant, synthetic, antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3046 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Total Volume — 10 Milliliter FDA UDI

Category: Bone matrix implant, synthetic, antimicrobial

Cerament® G by Bonesupport AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, antimicrobial.

Cleared under the same submission

DEN210044 also covers:

K234008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bonesupport AB

Sources (1)

  • FDA UDI b793939f-d208-4e42-b9bd-3b9217f06abd 37 fields · synced May 30, 2026