Who else makes this device?

Name: Simplex HV with Gentamicin
Brand: Simplex HV with Gentamicin

Orthopedic › ProstheticBone Cement, Antibiotic

Simplex HV With Gentamicin

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone…

Registry build 21.09.26

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code MBB
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Simplex HV with Gentamicin
Listed by	Osartis Gmbh, Germany
FDA product code	MBB
Device type	Bone Cement, Antibiotic
Device class	Class 2
Regulation	21 CFR 888.3027
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2015-09-24
Record revised	2020-06-19 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Store between 0°C (32°F) and 25°C (77°F); Handling environment temperature 17 to 25 °C
Packaging	Shipping unit of 2, dispenser box of 10
Sizes	Total volume 20 ml; weight 40.8 g

Catalogue Numbers

Catalogue numbers for Simplex HV with Gentamicin
Catalogue number	Size	Status
6195-1-001	Total Volume 20 ml	In distribution

Same Product Code

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Showing 12 of 44. All products under Bone Cement, Antibiotic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240856	2024-11-20

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Simplex HV with Gentamicin
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Howmedica Osteonics Corp	UDI-DI	2022-10-21	Class II	Under Investigation by firm	Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)	90 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.