Who else makes this device?

Name: Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Brand: Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Prosthesis, Hip, Hemi-, Femoral, Metal Ball → Orthopedic

5manufacturers in China registered for this device type

4catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), 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 LZY
Manufacturer	City	Province	Registered as	Device types
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Listed by	Smith & Nephew, Inc., United States
FDA product code	LZY
Device type	Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device class	Class 2
Regulation	21 CFR 888.3360
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K896580
Record published	2015-08-25
Record revised	2025-12-29 (version 7)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2022-03-17

Catalogue Numbers

Catalogue numbers for Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Catalogue number	Size	Status
126600		In distribution
126612		In distribution
126608		In distribution
126604		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Endohead	Medacta International SA	51
Quadra P femoral stems	Medacta International SA	27
Tandem	Smith & Nephew, Inc.	24
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Depuy Orthopaedics, Inc.	21
B-P Total HIP System	Endotec, Inc.	20
Balance Microplasty HIP System	Biomet Orthopedics	6
Sirius® Hip System	Biomet Orthopedics	3
Taperloc Microplasty HIP System	Biomet Orthopedics	3
Sirius	Biomet Orthopedics	3
Balance HIP System	Biomet Orthopedics	3
Cureguard	Jiangsu Cureguard Glove Co., Ltd.	1
Masterloc Femoral Stems	Medacta International SA	1

Showing 12 of 13. All products under Prosthesis, Hip, Hemi-, Femoral, Metal Ball

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231448	2023-07-19

Recalls

The FDA has not published a severity grade for these. 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	Closed
2009-01-12	Not classified	Process control	46 mm Femoral head was mismarked and packaged as being 45 mm	10 units	2011-03-25

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.

Prosthesis, Hip, Hemi-, Femoral, Metal Ball