Who else makes this device?

Name: TSP HIP FX Plating Systemguide Wire Placement Trocar
Brand: TSP HIP FX Plating Systemguide Wire Placement Trocar

Orthopedic › ProstheticDevice, Fixation, Proximal Femoral, Implant

TSP HIP FX Plating Systemguide Wire Placement Trocar

Catalogue number 14-451561, listed by Biomet Orthopedics, United States, under Device, Fixation, Proximal Femoral, Implant. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JDO
Manufacturer	City	Province	Registered as	Device types
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for TSP HIP FX Plating Systemguide Wire Placement Trocar
Listed by	Biomet Orthopedics, United States
FDA product code	JDO
Device type	Device, Fixation, Proximal Femoral, Implant
Device class	Class 2
Regulation	21 CFR 888.3030
510(k)	K140018
Record published	2016-09-26
Record revised	2025-05-30 (version 8)

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 TSP HIP FX Plating Systemguide Wire Placement Trocar
Catalogue number	Size	Status
14-451561		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BMP Compression HIP Screw	Biomet Orthopedics	112
DHS	Synthes Gmbh	93
THP™ Hip Fracture Plating System	Biomet Orthopedics	74
Percutaneous Compression Plate (Pc.c.p)	Orthofix SRL	69
Proform Hip System	Globus Medical, Inc.	51
Conquest FN	Smith & Nephew, Inc.	31
CHS	Smith & Nephew, Inc.	26
Large Cannulated Screws	Smith & Nephew, Inc.	22
TSP HIP FX Plating SYSTEM4.5MM Cortical NON – Locking Screw	Biomet Orthopedics	13
TSP HIP FX Plating SYSTEM4.5MM Cortical Locking Screw	Biomet Orthopedics	12
TSP HIP FX Plating SYSTEM7.5MM Telescoping LAG Screw	Biomet Orthopedics	6
Dhhs	Synthes Gmbh	6

Showing 12 of 112. All products under Device, Fixation, Proximal Femoral, Implant

Recalls Naming This Product

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

Recalls naming the identifiers of TSP HIP FX Plating Systemguide Wire Placement Trocar
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-01-07	Class II	Under Investigation by firm	Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.	1662	2021-04-08
Biomet, Inc.	510(k) number	2016-06-10	Class II	Device Design	The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw	5458 units	2017-07-20

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.