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.

Itotal® PS · Knee Arthroplasty Implantation System → Orthopedic

Name: iTotal® PS
Brand: iTotal® PS

2manufacturers in China registered for this device type

9catalogue numbers in this listing

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 iTotal® PS
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)	K160025
Record published	2016-10-24
Record revised	2022-08-17 (version 4)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	expiry date, serial number

Catalogue Numbers

Catalogue numbers for iTotal® PS
Catalogue number	Size	Status
RPS010180002	18mm thick on the medial side, lateral side is patient specific	In distribution
RPS010190002	19mm thick on the medial side, lateral side is patient specific	In distribution
RPS010150002	15mm thick on the medial side, lateral side is patient specific	In distribution
RPS010200002	20mm thick on the medial side, lateral side is patient specific	In distribution
RPS010160002	16mm thick on the medial side, lateral side is patient specific	In distribution
RPS101111302	Patient Specific	In distribution
RPS010060002	6mm thick on the medial side, lateral side is patient specific	In distribution
RPS010170002	17mm thick on the medial side, lateral side is patient specific	In distribution
RPS010210002	21mm thick on the medial side, lateral side is patient specific	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

510(K) Clearances

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

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 iTotal® PS
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
ConforMIS, Inc.	510(k) number	2016-10-18	Class II	Labeling Change Control	Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.	2 units	2016-12-07

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	7 units	2016-03-02
2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	71 units	2016-03-02
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.

Itotal® PS