What is FDA product code OOG?

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Orthopedic › ProstheticKnee Arthroplasty Implantation System

Signature(TM)

Name: Signature(TM)
Brand: Signature(TM)

2 catalogue numbers from 42-422405, listed by Biomet Orthopedics, United States, under Knee Arthroplasty Implantation System. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code OOG
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

Record

Regulatory record for Signature(TM)
Listed by	Biomet Orthopedics, United States
FDA product code	OOG
Device type	Knee Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3560
Record published	2016-09-22
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

Catalogue Numbers

Catalogue numbers for Signature(TM)
Catalogue number	Size	Status
42-422405		In distribution
42-422404		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prophecy	Microport Orthopedics Inc.	1,463
PointCloud Knee Instruments	Unik Orthopedics, Inc	202
iTotal Identity CR	ConforMIS, Inc.	138
My Knee Femoral Cutting Blocks	Medacta International SA	60
iTotal® CR iPoly™ Insert Kit	ConforMIS, Inc.	59
My Knee Tibial Cutting Blocks	Medacta International SA	48
My Knee Femoral Cutting Blocks MIS	Medacta International SA	42
My Knee Tibial Cutting Blocks MIS	Medacta International SA	36
iTotal® Identity Cruciate Retaining Knee Replacement System	ConforMIS, Inc.	27
iTotal® CR iPoly® XE Insert Kit	ConforMIS, Inc.	16
Zimmer Patient Specific Instruments	Materialise NV	12
iTotal Identity CR Knee Replacement System	ConforMIS, Inc.	12

Showing 12 of 95. All products under Knee Arthroplasty Implantation System

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.