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.

Zimmer Biomet Patient Specific Instruments · Knee Arthroplasty Implantation System → Orthopedic

Name: Zimmer Biomet Patient Specific Instruments
Brand: Zimmer Biomet Patient Specific Instruments

2manufacturers in China registered for this device type

3catalogue 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 Zimmer Biomet Patient Specific Instruments
Listed by	Materialise NV, Belgium
FDA product code	OOG
Device type	Knee Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3560
510(k)	K173970
Record published	2018-08-11
Record revised	2026-03-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Zimmer Biomet Patient Specific Instruments
Catalogue number	Size	Status
KNM-ZB14-00-01		In distribution
KNM-ZB11-00-01		In distribution
KNM-ZB01-00-01		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

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 Zimmer Biomet Patient Specific Instruments
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Materialise N.V.	510(k) number	2023-04-26	Class II	Process control	The wrong tibia guide was included intended for a different patient case.	2 Guides

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.

Zimmer Biomet Patient Specific Instruments