Who else makes this device?

Name: Actera HIP Reusable Trial Neck, Size 02-03 Standard
Brand: Actera HIP Reusable Trial Neck, Size 02-03 Standard

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

Actera HIP Reusable Trial Neck, Size 02-03 Standard

Catalogue number 1080-688, listed by ConforMIS, Inc., 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

1catalogue number

4510(k) clearances naming this product code

7recalls on this 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 Actera HIP Reusable Trial Neck, Size 02-03 Standard
Listed by	ConforMIS, Inc., 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
Establishment	Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K221104
Record published	2022-11-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Actera HIP Reusable Trial Neck, Size 02-03 Standard
Catalogue number	Size	Status
1080-688		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
K202484	2020-09-24
K192198	2019-11-06
K190904	2019-08-28
K162719	2017-06-14

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Actera HIP Reusable Trial Neck, Size 02-03 Standard
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
ConforMIS, Inc.	510(k) number	2023-06-16	Class II	Error in labeling	30mm screws were labeled as 25mm screws.	25 units

Recalls

7 of these are Class II. Class II means a temporary or reversible health consequence. 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
2025-03-25	Class II	Labeling Change Control	The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.	16
2020-09-21	Class II	Process control	Incorrect hip components were provided in kits.	2	2023-06-12
2019-08-22	Class II	Under Investigation by firm	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other’s packaging.	1	2020-07-08
2019-08-22	Class II	Under Investigation by firm	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other’s packaging.	1	2020-07-08
2019-03-29	Class II	Device Design	Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.	128	2020-04-28
2019-03-29	Class II	Device Design	Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.	183	2020-04-28
2018-10-16	Class II	Under Investigation by firm	The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.	1	2020-06-29

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.