Who else makes this device?

Name: Simplex
Brand: Simplex

Simplex · Bone Cement → Orthopedic

1manufacturer

4catalogue numbers in this listing

2510(k) clearances naming this product code

2recalls on this 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
Listed by	Howmedica Osteonics Corp, United States
FDA product code	LOD
Device type	Bone Cement
Device class	Class 2
Regulation	21 CFR 888.3027
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer
510(k)	K062553
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
Storage	Handling environment temperature 6 to 23 °C
Packaging	Case of 2, pack of 10
Sizes	Total volume 10 to 20 ml; weight 20 to 41 g

Catalogue Numbers

Catalogue numbers for Simplex
Catalogue number	Size	Status
6188-1-001	Total Volume 10.0 ml	In distribution
6191-1-001	Weight 40.0 g	In distribution
6197-9-001	Weight 41.0 g	In distribution
6192-1-001	Weight 40.0 g	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
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
Signature -x Cement	Teknimed SAS	3

Showing 12 of 63. All products under Bone Cement

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K053198	2006-01-26
K014199	2003-05-06

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Simplex
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Howmedica Osteonics Corp	510(k) number	2022-11-07	Class III	Under Investigation by firm	Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.	20 units

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-11-07	Class III	Under Investigation by firm	Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.	2085 units

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.

Simplex