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

Itotal® PS Ipoly™ Insert Kit

Name: iTotal® PS iPoly™ Insert Kit
Brand: iTotal® PS iPoly™ Insert Kit

11 catalogue numbers from RPS010120001, 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

11catalogue 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 iPoly™ Insert Kit
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)	K142161
Record published	2015-10-26
Record revised	2022-08-15 (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 iPoly™ Insert Kit
Catalogue number	Size	Status
RPS010120001	12mm thick on the medial side, lateral side is patient specific	In distribution
RPS010090001	9mm thick on the medial side, lateral side is patient specific	In distribution
RPS010080001	8mm thick on the medial side, lateral side is patient specific	In distribution
RPS010150001	15 MM THICK ON THE MEDIAL SIDE,LATERAL SIDE IS PATIENT SPECIFIC	In distribution
RPS010190001	19 mm thick on the side, lateral side is patient specific	In distribution
RPS010070001	7mm thick on the medial side, lateral side is patient specific	In distribution
RPS010110001	11mm thick on the medial side, lateral side is patient specific	In distribution
RPS010210001	21mm thick on the medial side, lateral side is patient specific	In distribution
RPS010060001	6 mm thick on the medial side, lateral side is patient specific	In distribution
RPS010170001	17mm thick on the medial side,lateral side is patient specific	In distribution
RPS010100001	10mm 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

10 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of iTotal® PS iPoly™ Insert Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
ConforMIS, Inc.	510(k) number	2020-02-03	Class II	Mixed-up of materials/components	A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.	2	2020-12-02
ConforMIS, Inc.	510(k) number	2019-01-04	Class II	Employee error	The labeling of the boxes and sterile pouches did not match the contents.	2	2020-06-29
ConforMIS, Inc.	510(k) number	2017-07-24	Class II	Employee error	Implant kit mislabeled	2 units	2019-02-01
ConforMIS, Inc.	510(k) number	2016-10-31	Class II	Software Design Change	iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).	1 unit	2017-01-11
ConforMIS, Inc.	510(k) number	2016-01-28	Class II	Packaging process control	Incorrect femoral component distributed	1 unit	2016-03-09
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	68 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	3 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	313 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	348 units	2016-03-02
ConforMIS, Inc.	510(k) number	2015-08-31	Class II	Process design	May contain small amounts of ethylene glycol residue	110 units	2016-03-02

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.