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

Mallory/Head Calcar HIP System

168 catalogue numbers from 108119, 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
168catalogue 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 Calcar 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) K031693
Record published 2015-10-24
Record revised 2025-05-30 (version 6)

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 Calcar HIP System
Catalogue number Size Status
108119 34E SIZE TYPE1 TAPER In distribution
11-104922 9 SIZE 260 MM TYPE1 TAPER In distribution
11-108251 11 SIZE 220 MM In distribution
CP154581 15 SIZE 220 MM TYPE I TAPER In distribution
21-108259 19 SIZE 220 MM In distribution
11-105008 55 – 65 MM In distribution
13-104914 45 – 55 MM In distribution
11-135170 21 SIZE 165 MM In distribution
21-108159 55E SIZE TYPE1 TAPER In distribution
11-108751 15 SIZE 240 MM In distribution
11-104987 19 SIZE 220 MM TYPE1 TAPER In distribution
21-108135 45C SIZE TYPE1 TAPER In distribution
11-104961 11 SIZE 220 MM TYPE1 TAPER In distribution
21-108155 55C SIZE TYPE1 TAPER In distribution
11-104956 17 SIZE 220 MM TYPE1 TAPER In distribution
11-108279 19 SIZE 250 MM In distribution
11-104948 9 SIZE 220 MM TYPE1 TAPER In distribution
CP154577 13 SIZE 220 MM TYPE I TAPER In distribution
11-104971 15 SIZE 220 MM TYPE1 TAPER In distribution
11-108753 17 SIZE 240 MM In distribution
11-104905 15 SIZE 170 MM TYPE1 TAPER In distribution
11-104989 19 SIZE 260 MM TYPE1 TAPER In distribution
11-104933 15 SIZE 260 MM TYPE1 TAPER In distribution
11-108453 13 SIZE 220 MM In distribution
CP154583 15 SIZE 260 MM TYPE I TAPER In distribution
11-104930 13 SIZE 260 MM TYPE1 TAPER In distribution
13-104915 55 – 65 MM In distribution
11-104963 11 SIZE 220 MM TYPE1 TAPER In distribution
11-104902 9 SIZE 170 MM TYPE1 TAPER In distribution
11-104962 11 SIZE 220 MM TYPE1 TAPER In distribution
11-104923 9 SIZE 260 MM TYPE1 TAPER In distribution
13-104912 50 – 60 MM In distribution
13-104913 60 – 70 MM In distribution
11-104934 15 SIZE 260 MM TYPE1 TAPER In distribution
108135 45C SIZE TYPE1 TAPER In distribution
CP154576 13 SIZE 260 MM TYPE I TAPER In distribution
11-104975 17 SIZE 220 MM TYPE1 TAPER In distribution
21-108132 45B SIZE TYPE1 TAPER In distribution
11-135167 18 SIZE 165 MM In distribution
21-108130 45A SIZE TYPE1 TAPER In distribution
CP154580 13 SIZE 260 MM TYPE I TAPER In distribution
11-104926 11 SIZE 260 MM TYPE1 TAPER In distribution
21-108157 55D SIZE TYPE1 TAPER In distribution
21-108273 13 SIZE 250 MM In distribution
21-108251 11 SIZE 220 MM In distribution
11-104968 13 SIZE 220 MM TYPE1 TAPER In distribution
11-104952 13 SIZE 220 MM TYPE1 TAPER In distribution
21-108112 34B SIZE TYPE1 TAPER In distribution
11-104974 17 SIZE 220 MM TYPE1 TAPER In distribution
21-108257 17 SIZE 220 MM In distribution
11-104988 19 SIZE 260 MM TYPE1 TAPER In distribution
11-104927 11 SIZE 260 MM TYPE1 TAPER In distribution
11-104938 17 SIZE 260 MM TYPE1 TAPER In distribution
11-104953 15 SIZE 220 MM TYPE1 TAPER In distribution
21-108275 15 SIZE 250 MM In distribution
11-108754 18 SIZE 240 MM In distribution
11-104924 9 SIZE 260 MM TYPE1 TAPER In distribution
11-104940 17 SIZE 260 MM TYPE1 TAPER In distribution
11-104928 11 SIZE 260 MM TYPE1 TAPER In distribution
11-104955 17 SIZE 220 MM TYPE1 TAPER In distribution
CP154574 13 SIZE 220 MM TYPE I TAPER In distribution
11-104912 50 – 60 MM In distribution
11-108255 15 SIZE 220 MM In distribution
13-104756 In distribution
21-108152 55B SIZE TYPE1 TAPER In distribution
11-108744 18 SIZE 200 MM In distribution
108710 65A SIZE TYPE1 TAPER In distribution
11-108093 13 SIZE 300 MM In distribution
11-104966 13 SIZE 220 MM TYPE1 TAPER In distribution
11-104950 11 SIZE 220 MM TYPE1 TAPER In distribution
11-104939 17 SIZE 260 MM TYPE1 TAPER In distribution
CP154622 11 SIZE 260 MM TYPE I TAPER In distribution
11-104947 9 SIZE 220 MM TYPE1 TAPER In distribution
108730 75A SIZE TYPE1 TAPER In distribution
21-108279 19 SIZE 250 MM In distribution
108137 45D SIZE TYPE1 TAPER In distribution
11-104959 9 SIZE 220 MM TYPE1 TAPER In distribution
CP154573 13 SIZE 220 MM TYPE I TAPER In distribution
CP154584 15 SIZE 260 MM TYPE I TAPER In distribution
21-108271 11 SIZE 250 MM In distribution
11-135163 14 SIZE 165 MM In distribution
11-104986 19 SIZE 220 MM TYPE1 TAPER In distribution
11-108750 14 SIZE 240 MM In distribution
11-104903 11 SIZE 170 MM TYPE1 TAPER In distribution
CP154575 13 SIZE 260 MM TYPE I TAPER In distribution
21-108119 34E SIZE TYPE1 TAPER In distribution
CP154621 11 SIZE 260 MM TYPE I TAPER In distribution
11-104935 15 SIZE 260 MM TYPE1 TAPER In distribution
11-104958 9 SIZE 220 MM TYPE1 TAPER In distribution
13-104911 40 – 50 MM In distribution
11-105007 50 – 60 MM In distribution
11-104967 13 SIZE 220 MM TYPE1 TAPER In distribution
11-108277 17 SIZE 250 MM In distribution
11-108457 17 SIZE 220 MM In distribution
11-108756 20 SIZE 240 MM In distribution
CP155888 45F SIZE TYPE I TAPER In distribution
11-104949 11 SIZE 220 MM TYPE1 TAPER In distribution
11-108259 19 SIZE 220 MM In distribution
CP154585 15 SIZE 220 MM TYPE I TAPER In distribution
21-108150 55A SIZE TYPE1 TAPER In distribution
11-104969 15 SIZE 220 MM TYPE1 TAPER In distribution
21-108137 45D SIZE TYPE1 TAPER In distribution
11-108273 13 SIZE 250 MM In distribution
11-104976 17 SIZE 220 MM TYPE1 TAPER In distribution
11-104914 45 – 55 MM In distribution
11-104925 11 SIZE 260 MM TYPE1 TAPER In distribution
CP154589 17 SIZE 220 MM TYPE I TAPER In distribution
11-104984 19 SIZE 220 MM TYPE1 TAPER In distribution
11-104977 19 SIZE 220 MM TYPE1 TAPER In distribution
11-108271 11 SIZE 250 MM In distribution
108150 55A SIZE TYPE1 TAPER In distribution
11-104965 13 SIZE 220 MM TYPE1 TAPER In distribution
11-108743 17 SIZE 200 MM In distribution
21-108253 13 SIZE 220 MM In distribution
11-104904 13 SIZE 170 MM TYPE1 TAPER In distribution
11-104937 17 SIZE 260 MM TYPE1 TAPER In distribution
11-108740 14 SIZE 200 MM In distribution
11-108745 19 SIZE 200 MM In distribution
11-108746 20 SIZE 200 MM In distribution
11-104972 15 SIZE 220 MM TYPE1 TAPER In distribution
108130 45A SIZE TYPE1 TAPER In distribution
11-135168 19 SIZE 165 MM In distribution
11-104921 9 SIZE 260 MM TYPE1 TAPER In distribution
11-104932 13 SIZE 260 MM TYPE1 TAPER In distribution
11-108095 15 SIZE 300 MM In distribution
11-108455 15 SIZE 220 MM In distribution
21-108115 34C SIZE TYPE1 TAPER In distribution
11-135161 12 SIZE 165 MM In distribution
11-104931 13 SIZE 260 MM TYPE1 TAPER In distribution
11-104954 15 SIZE 220 MM TYPE1 TAPER In distribution
11-104929 13 SIZE 260 MM TYPE1 TAPER In distribution
108112 34B SIZE TYPE1 TAPER In distribution
11-108451 11 SIZE 220 MM In distribution
11-108459 19 SIZE 220 MM In distribution
11-108097 17 SIZE 300 MM In distribution
11-104951 13 SIZE 220 MM TYPE1 TAPER In distribution
11-108742 16 SIZE 200 MM In distribution
11-108741 15 SIZE 200 MM In distribution
21-108117 34D SIZE TYPE1 TAPER In distribution
11-104978 19 SIZE 220 MM TYPE1 TAPER In distribution
11-105005 40 – 50 MM In distribution
11-104911 40 – 50 MM In distribution
108132 45B SIZE TYPE1 TAPER In distribution
11-104960 9 SIZE 220 MM TYPE1 TAPER In distribution
CP154619 11 SIZE 220 MM TYPE I TAPER In distribution
CP154620 11 SIZE 220 MM TYPE I TAPER In distribution
11-108253 13 SIZE 220 MM In distribution
11-104985 19 SIZE 220 MM TYPE1 TAPER In distribution
108110 34A SIZE TYPE1 TAPER In distribution
21-108139 45E SIZE TYPE1 TAPER In distribution
11-108099 19 SIZE 300 MM In distribution
11-108275 15 SIZE 250 MM In distribution
108157 55D SIZE TYPE1 TAPER In distribution
21-108277 17 SIZE 250 MM In distribution
11-104973 17 SIZE 220 MM TYPE1 TAPER In distribution
11-135166 17 SIZE 165 MM In distribution
11-108752 16 SIZE 240 MM In distribution
11-108755 19 SIZE 240 MM In distribution
21-108110 34A SIZE TYPE1 TAPER In distribution
11-104970 15 SIZE 220 MM TYPE1 TAPER In distribution
11-104957 9 SIZE 220 MM TYPE1 TAPER In distribution
11-104964 11 SIZE 220 MM TYPE1 TAPER In distribution
11-104936 15 SIZE 260 MM TYPE1 TAPER In distribution
11-108257 17 SIZE 220 MM In distribution
108152 55B SIZE TYPE1 TAPER In distribution
11-108091 11 SIZE 300 MM In distribution
21-108255 15 SIZE 220 MM In distribution
11-105006 45 – 55 MM 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

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

Recalls naming the identifiers of Mallory/Head Calcar HIP System
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Biomet, Inc. 510(k) number 2020-11-25 Class II Process control Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. 7428 2024-05-08
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 3 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 10 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 21 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 5 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 11 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 4 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 3 2010-10-18
Biomet, Inc. 510(k) number 2010-03-10 Not classified Process change control The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. 6 2010-10-18

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.

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