Who else makes this device?

Name: Simplex HV
Brand: Simplex HV

Simplex HV

Simplex® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and…

Registry build 21.09.26

Simplex® HV is a fast-setting acrylic resin 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 cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

1manufacturer

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Registered in Shanghai.

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

Record

Regulatory record for Simplex HV
Listed by	Osartis Gmbh, Germany
FDA product code	LOD
Device type	Bone Cement
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	Handling environment temperature 17 to 25 °C; Special storage condition: Store between 0°C (32°F) and 25°C (77°C)
Packaging	Shipping unit of 2, dispenser box of 10
Sizes	Total volume 20 ml; weight 40 g

Catalogue Numbers

Catalogue numbers for Simplex HV
Catalogue number	Size	Status
6194-1-001	Total Volume 20 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Palacos	Heraeus Medical LLC	17
Kiva	Benvenue Medical, Inc.	6
Rally	Smith & Nephew, Inc.	5
Bone Cement	Depuy (Ireland)	5
PCD SpinePlex	Stryker GmbH	4
Simplex	Howmedica Osteonics Corp	4
DJO Surgical	Encore Medical, L.P.	4
Gentafix	Teknimed SAS	3
Versabond	Smith & Nephew, Inc.	3
Orthoset®	Microport Orthopedics Inc.	3
Osteopal®	Heraeus Medical LLC	3
Prostalac	Depuy Orthopaedics, Inc.	3

Showing 12 of 63. All products under Bone Cement

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K202458	2021-05-18
K210125	2021-03-19
K210120	2021-03-19
K192394	2019-12-02
K192379	2019-11-27

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P970010	2000-08-31	NORIAN SRS BONE CEMENT	Synthes (Usa)
P960001	1999-08-26	DEPUY 3 BONE CEMENT	Depuy Intl., Ltd.
N18466	1998-10-21	ORTHOSET BONE CEMENT	Depuy Intl., Ltd.
N17004	1996-12-18	SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT	Howmedica Corp.
N17003	1993-06-08	SURGICAL SIMPLEX(R) P BONE CEMENT	Howmedica Corp.
P810020	1992-02-14	PALACOS R BONE CEMENT	Smith & Nephew Richards, Inc.
N17755	1990-08-02	BONECEMENT	Zimmer, Inc.
N17113	1981-09-16	OMNIPLASTIC BONE CEMENT	L.D. Caulk Co.

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.