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 Type 12 / 14 Provisional Head

Name: G7 Type 12 / 14 Provisional Head
Brand: G7 Type 12 / 14 Provisional Head

3 catalogue numbers from 010002537, listed by Biomet Orthopedics, 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

3catalogue numbers in this listing

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 Type 12 / 14 Provisional Head
Listed by	Biomet Orthopedics, 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
510(k)	K121874
Record published	2016-10-26
Record revised	2025-05-30 (version 7)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for G7 Type 12 / 14 Provisional Head
Catalogue number	Size	Status
010002537	32MM, -4MM NECK LENGTH	In distribution
010002534	32MM, +8MM NECK LENGTH	In distribution
010002539	36MM, +4MM NECK LENGTH	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
Echo BI-Metric Microplasty HIP System	Biomet Orthopedics	3

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

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 G7 Type 12 / 14 Provisional Head
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Zimmer, Inc.	510(k) number	2022-08-25	Class II	Under Investigation by firm	The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery	56 US
Biomet, Inc.	510(k) number	2014-05-07	Class II	Use error	Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.	1047 total	2015-10-30
Biomet, Inc.	510(k) number	2014-05-07	Class II	Use error	Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.	1047 total	2015-10-30

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.