Who else makes this device?

Name: Encompass Hip Stem
Brand: Encompass Hip Stem

Encompass Hip Stem · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented → Orthopedic

13manufacturers in China registered for this device type

18catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDI
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
B-ONE Medical (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	Contract manufacturer	7
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54

Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Record

Regulatory record for Encompass Hip Stem
Listed by	Ortho Development Corp., United States
FDA product code	JDI
Device type	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class	Class 2
Regulation	21 CFR 888.3350
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K050637
Record published	2015-08-31
Record revised	2018-07-06 (version 3)

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
Sizes	Outer diameter 6 to 18 mm; width 13 to 19 mm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Encompass Hip Stem
Catalogue number	Size	Status
106-0017	Outer Diameter 17 mm	In distribution
106-1017	Width 17 mm	In distribution
107-1017	Width 17 mm	In distribution
107-0613	Width 13 mm	In distribution
106-0014	Outer Diameter 14 mm	In distribution
106-0815	Outer Diameter 8 mm	In distribution
107-1219	Outer Diameter 12 mm	In distribution
107-0815	Outer Diameter 8 mm	In distribution
106-0012	Outer Diameter 12 mm	In distribution
106-0009	Outer Diameter 9 mm	In distribution
106-0010	Outer Diameter 10 mm	In distribution
106-0013	Outer Diameter 13 mm	In distribution
106-0018	Outer Diameter 18 mm	In distribution
106-0011	Outer Diameter 11 mm	In distribution
106-0015	Outer Diameter 15 mm	In distribution
106-0613	Width 13 mm	In distribution
106-0016	Outer Diameter 16 mm	In distribution
106-1219	Outer Diameter 12 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Zimmer, Inc.	836
R3	Smith & Nephew, Inc.	497
UniSyn Hip System	Shalby Advanced Technologies, Inc.	247
UniSyn® Hip System	Consensus Orthopedics, Inc.	247
Reflection	Smith & Nephew, Inc.	170
Instrument	Howmedica Osteonics Corp	167
Echelon	Smith & Nephew, Inc.	159
B-P Total HIP System	Endotec, Inc.	151
ZCA®	Zimmer, Inc.	149
Omnifit	Howmedica Osteonics Corp	149
Ringloc HIP System	Biomet Orthopedics	139
Profemur	Microport Orthopedics Inc.	113

Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K153216	2016-02-18
K050637	2005-09-23
K051407	2005-09-08
K971581	1997-07-18

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.

Encompass Hip Stem