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

Iuni® Unicondylar Knee Replacement System

Name: iUni® Unicondylar Knee Replacement System
Brand: iUni® Unicondylar Knee Replacement System

Catalogue number UKA111111101, listed by ConforMIS, Inc., 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

1catalogue number

1510(k) clearance

3recalls on this code

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 iUni® Unicondylar Knee Replacement System
Listed by	ConforMIS, Inc., United States
FDA product code	OOG
Device type	Knee Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3560
Establishment	Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K132640
Record published	2015-10-26
Record revised	2022-08-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	expiry date, serial number
Distribution end date	2022-08-15

Catalogue Numbers

Catalogue numbers for iUni® Unicondylar Knee Replacement System
Catalogue number	Size	Status
UKA111111101	Patient Specific	Withdrawn

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K203421	2021-04-19

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 iUni® Unicondylar Knee Replacement System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	7 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	71 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	6 units	2016-03-02

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.