Who else makes this device?

Name: Mallory-Head® Primary Hip System
Brand: Mallory-Head® Primary Hip System

Orthopedic › ProstheticProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Mallory-Head® Primary Hip System

37 catalogue numbers from 11-104210, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26

14manufacturers in China registered for this device type

37catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LPH
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
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Guangzhou Aquila Precise Tools Limited	Guangzhou	Guangdong	Contract manufacturer	28
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
Lincotek (Wuxi) Co., Ltd.	Wuxi	Jiangsu	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

Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Record

Regulatory record for Mallory-Head® Primary Hip System
Listed by	Biomet Orthopedics, United States
FDA product code	LPH
Device type	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class	Class 2
Regulation	21 CFR 888.3358
510(k)	K000538
Record published	2019-02-15
Record revised	2025-05-30 (version 5)

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

Catalogue Numbers

Catalogue numbers for Mallory-Head® Primary Hip System
Catalogue number	Size	Status
11-104210	10 Size 155 mm Type1 Taper	In distribution
11-104107	7 Size 140 mm Type1 Taper	In distribution
21-124310	10 SIZE 155 MM TYPE1 TAPER	In distribution
11-104113	13 Size 170 mm Type1 Taper	In distribution
11-104209	9 Size 150 mm Type1 Taper	In distribution
11-104213	13 SIZE 170 MM TYPE1 TAPER	In distribution
11-104109	9 Size 150 mm Type1 Taper	In distribution
11-104114	14 Size 175 mm Type1 Taper	In distribution
11-104216	16 SIZE 180 MM TYPE1 TAPER	In distribution
11-104217	17 Size 180 mm Type1 Taper	In distribution
11-104110	10 SIZE 155 MM TYPE1 TAPER	In distribution
11-104118	18 SIZE 180 MM TYPE1 TAPER	In distribution
21-104116	16 Size 180 mm Type1 Taper	In distribution
11-104215	15 Size 180 mm Type1 Taper	In distribution
11-104118	18 Size 180 mm Type1 Taper	In distribution
11-104211	11 Size 160 mm Type1 Taper	In distribution
11-104108	8 Size 145 mm Type1 Taper	In distribution
11-104217	17 Size 180 mm Type1 Taper	In distribution
21-104111	11 SIZE 160 MM TYPE1 TAPER	In distribution
21-104109	9 Size 150 mm Type1 Taper	In distribution
21-104116	16 SIZE 180 MM TYPE1 TAPER	In distribution
21-104118	18 SIZE 180 MM TYPE1 TAPER	In distribution
21-124311	11 SIZE 160 MM TYPE1 TAPER	In distribution
21-104118	18 Size 180 mm Type1 Taper	In distribution
11-104211	11 Size 160 mm Type1 Taper	In distribution
11-104216	16 Size 180 mm Type1 Taper	In distribution
11-104108	8 SIZE 145 MM TYPE1 TAPER	In distribution
21-104117	17 Size 180 mm Type1 Taper	In distribution
11-104110	10 Size 155 mm Type1 Taper	In distribution
11-104213	13 Size 170 mm Type1 Taper	In distribution
11-104215	15 Size 180 mm Type1 Taper	In distribution
11-104113	13 Size 170 mm Type1 Taper	In distribution
21-104115	15 SIZE 180 MM TYPE1 TAPER	In distribution
11-104210	10 SIZE 155 MM TYPE1 TAPER	In distribution
11-104208	8 Size 145 mm Type1 Taper	In distribution
11-104111	11 Size 160 mm Type1 Taper	In distribution
11-104212	12 Size 165 mm Type1 Taper	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Initia Total Hip System	Kyocera Medical Technologies, Inc.	1,000
DJO Surgical	Encore Medical, L.P.	624
Pinnacle	Depuy Orthopaedics, Inc.	613
Trilogy® Longevity®	Zimmer, Inc.	564
Instrument	Howmedica Osteonics Corp	369
InSitu Hip System	Nextstep Arthropedix	368
Trilogy®	Zimmer, Inc.	359
Kyocera Medical Technologies, Inc.	Kyocera Medical Technologies, Inc.	298
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Zimmer, Inc.	286
Bencox Hip System	Corentec Co., Ltd.	286
OrthoMedFlex	Orthomedflex LLC	257
Sterizo Total Hip System	CPM Medical Consultants, LLC.	240

Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K030048	2003-02-05
K023357	2002-11-06
K022463	2002-08-16
K001660	2000-06-14

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Mallory-Head® Primary Hip System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2019-08-21	Class II	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.	219988 units (total)	2021-07-21
Biomet, Inc.	510(k) number	2015-04-16	Class III	Labeling mix-ups	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.	1315	2016-05-16
Biomet, Inc.	510(k) number	2015-01-09	Class II	Packaging process control	Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.	17	2015-10-22

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
P880025	1991-12-04	AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS	Depuy Intl., Ltd.
P880076	1991-06-17	WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS	Dow Corning Wright
P850061	1991-03-08	BIAS(R) FIBER METAL TOTAL HIP SYSTEM	Zimmer, Inc.

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.