What is FDA product code PBI?

For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Orthopedic › ProstheticProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

G7®

Name: G7®
Brand: G7®

2 catalogue numbers from 110041050, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PBI
Manufacturer	City	Province	Registered as	Device types
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
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

Record

Regulatory record for G7®
Listed by	Zimmer, Inc., United States
FDA product code	PBI
Device type	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Device class	Class 2
Regulation	21 CFR 888.3310
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published	2020-05-08
Record revised	2024-11-04 (version 3)

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 G7®
Catalogue number	Size	Status
110041050	Size D	In distribution
110042000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
G7®	Biomet Orthopedics	45
G7 Acetabular Liner	Biomet Orthopedics	37
Arcos® One-Piece Revision System	Biomet Orthopedics	17
G7® Acetabular System	Biomet Orthopedics	13
G7 Osseoti Acetabular Shell	Biomet Orthopedics	8
Sirius®	Biomet Orthopedics	6
G7® Revision Acetabular System	Zimmer, Inc.	5
G7 Provisional Neutral Liner	Biomet Orthopedics	4
Echo BI-Metric Microplasty HIP Stem	Biomet Orthopedics	4
G7® Freedom® Vivacit-E®	Zimmer, Inc.	4
Sirius HIP System	Biomet Orthopedics	3
G7 Type 12 / 14 Provisional Head	Biomet Orthopedics	3

Showing 12 of 34. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212512	2022-04-28

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.

G7®