Who else makes this device?

Name: Integra®
Brand: Integra®

Integra® · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented → Orthopedic

8manufacturers in China registered for this device type

14catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HSD
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Integra®
Listed by	Ascension Orthopedics, Inc., United States
FDA product code	HSD
Device type	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class	Class 2
Regulation	21 CFR 888.3690
Establishment	Manufacturer
510(k)	K062861
Record published	2016-08-15
Record revised	2023-01-25 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2026-12-31

Catalogue Numbers

Catalogue numbers for Integra®
Catalogue number	Size	Status
TRL9005218	2.047 in dia x.707 in H	In distribution
TRL9004820	1.89 in dia x.785 in H	In distribution
TRL9004415	1.732 in dia x.589 in H	In distribution
SHP9004820	Size 48/20	In distribution
SHP9005221	Size 52/21	In distribution
TRL9004016	1.575 in dia x.628 in H	In distribution
TRL9005221	2.047 in dia x.825 in H	In distribution
SHP9004817	Size 48/17	In distribution
SHP9004418	Size 44/18	In distribution
TRL9004817	1.89 in dia x.667 in H	In distribution
TRL9005621	2.245 in dia x.825 in H	In distribution
TRL9004418	1.732 in dia x.707 in H	In distribution
SHP9005621	Size 56/21	In distribution
SHP9005218	Size 52/18	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	345
SMR Shoulder	Limacorporate	182
FX V135	Fx Shoulder Solutions SAS	127
Acumed	Acumed LLC	112
Promos	Smith & Nephew, Inc.	104
Trabecular Metal®	Zimmer, Inc.	90
Bigliani/Flatow®	Zimmer, Inc.	86
Comprehensive® Shoulder System	Biomet Orthopedics	85
Arthrex®	Arthrex, Inc.	75
SMR System	Limacorporate	72
DJO Surgical	Encore Medical, L.P.	70
Humeris Shoulder	Fx Solutions	69

Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K071064	2007-06-22
K062861	2006-10-31

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 Integra®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Closed
Ascension Orthopedics, Inc.	510(k) number	2018-11-16	Class III	Vendor change control	The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).	2019-11-22

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.

Integra®