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

Mallory-Head® Primary Hip System

54 catalogue numbers from 11-104106, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26
14manufacturers in China registered for this device type
54catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MEH
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
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
Lincotek (Wuxi) Co., Ltd. Wuxi Jiangsu Contract manufacturer 7
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
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

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

Record

Regulatory record for Mallory-Head® Primary Hip System
Listed by Biomet Orthopedics, United States
FDA product code MEH
Device type Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class Class 2
Regulation 21 CFR 888.3353
510(k) K030055
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
11-104106 6 Size 135 mm Type1 Taper In distribution
11-104211 11 SIZE 160 MM TYPE1 TAPER In distribution
21-104110 10 SIZE 155 MM TYPE1 TAPER In distribution
11-104213 13 Size 170 mm Type1 Taper In distribution
21-104112 12 Size 165 mm Type1 Taper In distribution
11-104209 9 Size 150 mm Type1 Taper In distribution
11-104116 16 SIZE 180 MM TYPE1 TAPER In distribution
11-104208 8 SIZE 145 MM TYPE1 TAPER In distribution
11-104208 8 Size 145 mm Type1 Taper In distribution
11-104214 14 Size 175 mm Type1 Taper In distribution
11-104210 10 Size 155 mm Type1 Taper In distribution
21-104114 14 Size 175 mm Type1 Taper In distribution
11-104214 14 SIZE 175 MM TYPE1 TAPER In distribution
21-104109 9 SIZE 150 MM TYPE1 TAPER In distribution
21-124317 17 SIZE 180 MM TYPE1 TAPER In distribution
21-124316 16 SIZE 180 MM TYPE1 TAPER In distribution
11-104216 16 Size 180 mm Type1 Taper In distribution
11-104112 12 SIZE 165 MM TYPE1 TAPER In distribution
11-104209 9 SIZE 150 MM TYPE1 TAPER In distribution
21-104117 17 SIZE 180 MM TYPE1 TAPER In distribution
11-104117 17 Size 180 mm Type1 Taper In distribution
21-104111 11 Size 160 mm Type1 Taper In distribution
21-104110 10 Size 155 mm Type1 Taper In distribution
11-104217 17 SIZE 180 MM TYPE1 TAPER In distribution
11-104106 6 SIZE 135 MM TYPE1 TAPER In distribution
11-104212 12 Size 165 mm Type1 Taper In distribution
21-104115 15 Size 180 mm Type1 Taper In distribution
11-104113 13 SIZE 170 MM TYPE1 TAPER In distribution
11-104215 15 SIZE 180 MM TYPE1 TAPER In distribution
11-104107 7 SIZE 140 MM TYPE1 TAPER In distribution
21-104112 12 SIZE 165 MM TYPE1 TAPER In distribution
21-104113 13 Size 170 mm Type1 Taper In distribution
11-104214 14 Size 175 mm Type1 Taper In distribution
11-104119 19 SIZE 180 MM TYPE1 TAPER In distribution
21-124313 13 SIZE 170 MM TYPE1 TAPER In distribution
21-104119 19 SIZE 180 MM TYPE1 TAPER In distribution
11-104117 17 SIZE 180 MM TYPE1 TAPER In distribution
11-104119 19 Size 180 mm Type1 Taper In distribution
21-124314 14 SIZE 175 MM TYPE1 TAPER In distribution
11-104110 10 Size 155 mm Type1 Taper In distribution
21-124312 12 SIZE 165 MM TYPE1 TAPER In distribution
11-104109 9 Size 150 mm Type1 Taper In distribution
11-104115 15 SIZE 180 MM TYPE1 TAPER In distribution
11-104119 19 Size 180 mm Type1 Taper In distribution
21-104113 13 SIZE 170 MM TYPE1 TAPER In distribution
11-104111 11 SIZE 160 MM TYPE1 TAPER In distribution
21-104114 14 SIZE 175 MM TYPE1 TAPER In distribution
21-104119 19 Size 180 mm Type1 Taper In distribution
11-104212 12 SIZE 165 MM TYPE1 TAPER In distribution
21-124315 15 SIZE 180 MM TYPE1 TAPER In distribution
11-104112 12 Size 165 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
21-124309 9 SIZE 150 MM TYPE1 TAPER In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alteon Exactech, Inc. 326
Novation Exactech, Inc. 317
Pinnacle Depuy Orthopaedics, Inc. 305
SP-CL Hip Stem Waldemar Link GmbH & Co. KG 219
Emperion Smith & Nephew, Inc. 201
MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG 154
Instrument Howmedica Osteonics Corp 145
Restoration Howmedica Osteonics Corp 144
Mfinity Femoral System Medacta International SA 138
Echelon Smith & Nephew, Inc. 134
Trinity Acetabular Hip System Corin Limited 128
Redapt Smith & Nephew, Inc. 127

Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K021403 2002-05-31
K020963 2002-04-16

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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer