What is FDA product code OIY?

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Orthopedic › ProstheticProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Persona® Vivacit-E®

Name: Persona® Vivacit-E®
Brand: Persona® Vivacit-E®

332 catalogue numbers from 42-5126-001-12, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

332catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OIY
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	Contract manufacturer	7
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Persona® Vivacit-E®
Listed by	Zimmer, Inc., United States
FDA product code	OIY
Device type	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class	Class 2
Regulation	21 CFR 888.3560
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K123459
Record published	2016-08-08
Record revised	2022-03-17 (version 5)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Height 10 to 20 mm

Catalogue Numbers

Catalogue numbers for Persona® Vivacit-E®
Catalogue number	Size	Status
42-5126-001-12	Height 12 mm	In distribution
42-5224-005-16	Height 16 mm	In distribution
42-5120-006-11	Height 11 mm	In distribution
42-5122-006-10	Height 10 mm	In distribution
42-5121-010-12	Height 12 mm	In distribution
42-5220-005-14	Height 14 mm	In distribution
42-5121-009-11	Height 11 mm	In distribution
42-5121-004-11	CR Femur Sizes 6-7	In distribution
42-5121-003-14	CR Femur Sizes 4-5	In distribution
42-5224-008-12	Height 12 mm	In distribution
42-5124-007-12	Height 12 mm	In distribution
42-5224-004-12	Height 12 mm	In distribution
42-5121-009-11	Height 11 mm	In distribution
42-5121-011-11	CR Femur Size 12	In distribution
42-5121-007-18	CR Femur Sizes 6-7	In distribution
42-5222-001-13	Height 13 mm	In distribution
42-5124-003-16	Height 16 mm	In distribution
42-5221-010-11	CR Femur Size 12	In distribution
42-5121-008-10	CR Femur Sizes 8-11	In distribution
42-5224-002-11	Height 11 mm	In distribution
42-5121-007-11	Height 11 mm	In distribution
42-5122-007-12	Height 12 mm	In distribution
42-5126-005-10	Height 10 mm	In distribution
42-5126-004-20	Height 20 mm	In distribution
42-5124-005-13	Height 13 mm	In distribution
42-5121-010-11	CR Femur Size 12	In distribution
42-5121-003-18	Height 18 mm	In distribution
42-5221-010-20	Height 20 mm	In distribution
42-5126-008-14	Height 14 mm	In distribution
42-5124-004-16	Height 16 mm	In distribution
42-5226-001-11	Height 11 mm	In distribution
42-5124-009-20	Height 20 mm	In distribution
42-5122-004-20	Height 20 mm	In distribution
42-5121-010-11	Height 11 mm	In distribution
42-5221-001-16	Height 16 mm	In distribution
42-5226-011-13	Height 13 mm	In distribution
42-5121-004-16	CR Femur Sizes 6-7	In distribution
42-5224-005-14	Height 14 mm	In distribution
42-5122-002-10	Height 10 mm	In distribution
42-5221-011-12	CR Femur Size 12	In distribution
42-5226-010-13	Height 13 mm	In distribution
42-5120-003-14	Height 14 mm	In distribution
42-5222-007-13	Height 13 mm	In distribution
42-5122-002-12	Height 12 mm	In distribution
42-5402-000-32	32 mm, Diameter, 8.5 mm, Thickness	In distribution
42-5126-001-18	Height 18 mm	In distribution
42-5222-004-18	Height 18 mm	In distribution
42-5126-005-13	Height 13 mm	In distribution
42-5121-005-11	CR Femur Sizes 8-9	In distribution
42-5121-001-14	Height 14 mm	In distribution
42-5126-005-12	Height 12 mm	In distribution
42-5221-007-14	Height 14 mm	In distribution
42-5221-006-13	CR Femur Sizes 4-5	In distribution
42-5224-004-11	Height 11 mm	In distribution
42-5121-008-11	Height 11 mm	In distribution
42-5226-011-10	Height 10 mm	In distribution
42-5221-008-11	CR Femur Sizes 8-11	In distribution
42-5121-004-20	CR Femur Sizes 6-7	In distribution
42-5121-003-10	CR Femur Sizes 4-5	In distribution
42-5222-007-12	Height 12 mm	In distribution
42-5226-001-13	Height 13 mm	In distribution
42-5122-001-10	Height 10 mm	In distribution
42-5221-004-14	Height 14 mm	In distribution
42-5121-003-20	Height 20 mm	In distribution
42-5122-004-10	Height 10 mm	In distribution
42-5221-011-16	Height 16 mm	In distribution
42-5220-006-12	Height 12 mm	In distribution
42-5220-001-14	Height 14 mm	In distribution
42-5221-004-11	Height 11 mm	In distribution
42-5121-004-10	Height 10 mm	In distribution
42-5221-006-18	CR Femur Sizes 4-5	In distribution
42-5224-007-13	Height 13 mm	In distribution
42-5122-006-11	Height 11 mm	In distribution
42-5121-006-20	Height 20 mm	In distribution
42-5221-003-14	Height 14 mm	In distribution
42-5226-004-13	Height 13 mm	In distribution
42-5120-006-18	Height 18 mm	In distribution
42-5121-007-16	CR Femur Sizes 6-7	In distribution
42-5126-004-16	Height 16 mm	In distribution
42-5221-003-10	Height 10 mm	In distribution
42-5121-011-11	Height 11 mm	In distribution
42-5124-011-16	Height 16 mm	In distribution
42-5126-003-16	Height 16 mm	In distribution
42-5120-002-16	Height 16 mm	In distribution
42-5222-005-12	Height 12 mm	In distribution
42-5226-003-20	Height 20 mm	In distribution
42-5126-004-12	Height 12 mm	In distribution
42-5224-001-16	Height 16 mm	In distribution
42-5124-003-10	Height 10 mm	In distribution
42-5126-003-11	Height 11 mm	In distribution
42-5221-002-14	Height 14 mm	In distribution
42-5122-002-20	Height 20 mm	In distribution
42-5221-009-14	CR Femur Sizes 8-11	In distribution
42-5224-005-11	Height 11 mm	In distribution
42-5224-004-16	Height 16 mm	In distribution
42-5124-003-20	Height 20 mm	In distribution
42-5126-005-18	Height 18 mm	In distribution
42-5220-007-10	Height 10 mm	In distribution
42-5221-002-16	Height 16 mm	In distribution
42-5221-010-16	Height 16 mm	In distribution
42-5221-001-14	Height 14 mm	In distribution
42-5126-002-18	Height 18 mm	In distribution
42-5226-004-20	Height 20 mm	In distribution
42-5221-009-10	Height 10 mm	In distribution
42-5221-009-16	Height 16 mm	In distribution
42-5224-001-11	Height 11 mm	In distribution
42-5120-007-18	Height 18 mm	In distribution
42-5226-006-12	Height 12 mm	In distribution
42-5221-001-10	Height 10 mm	In distribution
42-5121-005-18	Height 18 mm	In distribution
42-5126-001-11	Height 11 mm	In distribution
42-5221-007-16	CR Femur Sizes 6-7	In distribution
42-5221-007-20	Height 20 mm	In distribution
42-5121-009-13	Height 13 mm	In distribution
42-5221-007-10	Height 10 mm	In distribution
42-5222-004-12	Height 12 mm	In distribution
42-5121-002-10	Height 10 mm	In distribution
42-5226-003-13	Height 13 mm	In distribution
42-5224-010-13	Height 13 mm	In distribution
42-5126-010-18	Height 18 mm	In distribution
42-5126-011-10	Height 10 mm	In distribution
42-5120-004-10	Height 10 mm	In distribution
42-5120-002-12	Height 12 mm	In distribution
42-5121-009-16	CR Femur Sizes 8-11	In distribution
42-5126-011-18	Height 18 mm	In distribution
42-5126-004-10	Height 10 mm	In distribution
42-5124-006-16	Height 16 mm	In distribution
42-5122-001-20	Height 20 mm	In distribution
42-5224-001-14	Height 14 mm	In distribution
42-5122-001-16	Height 16 mm	In distribution
42-5220-002-10	Height 10 mm	In distribution
42-5222-004-13	Height 13 mm	In distribution
42-5221-010-10	Height 10 mm	In distribution
42-5126-009-16	Height 16 mm	In distribution
42-5120-007-11	Height 11 mm	In distribution
42-5220-007-12	Height 12 mm	In distribution
42-5221-007-11	Height 11 mm	In distribution
42-5220-001-10	Height 10 mm	In distribution
42-5121-011-13	Height 13 mm	In distribution
42-5221-009-18	Height 18 mm	In distribution
42-5121-003-18	Height 18 mm	In distribution
42-5122-006-12	Height 12 mm	In distribution
42-5224-008-11	Height 11 mm	In distribution
42-5124-004-12	Height 12 mm	In distribution
42-5222-003-11	Height 11 mm	In distribution
42-5221-004-12	Height 12 mm	In distribution
42-5224-009-20	Height 20 mm	In distribution
42-5221-003-20	CR Femur Sizes 4-5	In distribution
42-5126-008-16	Height 16 mm	In distribution
42-5221-001-16	CR Femur Sizes 1-2	In distribution
42-5124-011-18	Height 18 mm	In distribution
42-5121-009-14	CR Femur Sizes 8-11	In distribution
42-5126-004-11	Height 11 mm	In distribution
42-5221-005-20	Height 20 mm	In distribution
42-5122-007-11	Height 11 mm	In distribution
42-5120-004-16	Height 16 mm	In distribution
42-5221-010-14	Height 14 mm	In distribution
42-5226-004-12	Height 12 mm	In distribution
42-5221-006-20	Height 20 mm	In distribution
42-5224-002-16	Height 16 mm	In distribution
42-5226-002-12	Height 12 mm	In distribution
42-5224-008-18	Height 18 mm	In distribution
42-5121-001-18	Height 18 mm	In distribution
42-5220-003-16	Height 16 mm	In distribution
42-5121-001-16	Height 16 mm	In distribution
42-5124-005-20	Height 20 mm	In distribution
42-5221-008-16	Height 16 mm	In distribution
42-5122-006-13	Height 13 mm	In distribution
42-5124-011-20	Height 20 mm	In distribution
42-5221-005-14	Height 14 mm	In distribution
42-5224-003-10	Height 10 mm	In distribution
42-5226-005-12	Height 12 mm	In distribution
42-5226-007-11	Height 11 mm	In distribution
42-5124-008-11	Height 11 mm	In distribution
42-5126-003-18	Height 18 mm	In distribution
42-5226-009-13	Height 13 mm	In distribution
42-5121-007-20	Height 20 mm	In distribution
42-5224-007-10	Height 10 mm	In distribution
42-5220-005-12	Height 12 mm	In distribution
42-5226-006-13	Height 13 mm	In distribution
42-5221-006-10	CR Femur Sizes 4-5	In distribution
42-5224-010-12	Height 12 mm	In distribution
42-5221-005-11	Height 11 mm	In distribution
42-5221-007-10	Height 10 mm	In distribution
42-5221-006-11	CR Femur Sizes 4-5	In distribution
42-5221-008-12	Height 12 mm	In distribution
42-5124-009-10	Height 10 mm	In distribution
42-5124-001-13	Height 13 mm	In distribution
42-5221-002-12	Height 12 mm	In distribution
42-5221-011-16	Height 16 mm	In distribution
42-5126-005-16	Height 16 mm	In distribution
42-5221-006-10	Height 10 mm	In distribution
42-5121-005-13	CR Femur Sizes 8-9	In distribution
42-5226-001-18	Height 18 mm	In distribution
42-5221-002-13	Height 13 mm	In distribution
42-5121-011-18	Height 18 mm	In distribution
42-5222-006-10	Height 10 mm	In distribution
42-5124-009-14	Height 14 mm	In distribution
42-5226-006-20	Height 20 mm	In distribution
42-5122-005-10	Height 10 mm	In distribution
42-5126-002-10	Height 10 mm	In distribution
42-5222-005-16	Height 16 mm	In distribution
42-5121-010-20	Height 20 mm	In distribution
42-5222-001-11	Height 11 mm	In distribution
42-5226-004-16	Height 16 mm	In distribution
42-5121-009-20	Height 20 mm	In distribution
42-5221-005-10	Height 10 mm	In distribution
42-5220-002-12	Height 12 mm	In distribution
42-5221-007-11	Height 11 mm	In distribution
42-5126-010-16	Height 16 mm	In distribution
42-5120-002-14	Height 14 mm	In distribution
42-5222-001-18	Height 18 mm	In distribution
42-5226-006-18	Height 18 mm	In distribution
42-5121-005-12	Height 12 mm	In distribution
42-5122-007-18	Height 18 mm	In distribution
42-5226-003-14	Height 14 mm	In distribution
42-5220-006-16	Height 16 mm	In distribution
42-5126-009-18	Height 18 mm	In distribution
42-5226-004-18	Height 18 mm	In distribution
42-5126-004-18	Height 18 mm	In distribution
42-5221-004-13	Height 13 mm	In distribution
42-5121-007-14	Height 14 mm	In distribution
42-5226-002-20	Height 20 mm	In distribution
42-5222-005-20	Height 20 mm	In distribution
42-5220-005-16	Height 16 mm	In distribution
42-5226-011-20	Height 20 mm	In distribution
42-5222-003-16	Height 16 mm	In distribution
42-5226-008-20	Height 20 mm	In distribution
42-5402-000-41	41 mm, Diameter, 10.0 mm, Thickness	In distribution
42-5121-006-14	CR Femur Sizes 4-5	In distribution
42-5221-008-14	Height 14 mm	In distribution
42-5121-001-12	CR Femur Sizes 1-2	In distribution
42-5126-006-13	Height 13 mm	In distribution
42-5121-008-18	CR Femur Sizes 8-11	In distribution
42-5122-002-16	Height 16 mm	In distribution
42-5224-003-13	Height 13 mm	In distribution
42-5221-005-20	Height 20 mm	In distribution
42-5121-002-10	Height 10 mm	In distribution
42-5121-011-10	Height 10 mm	In distribution
42-5222-002-12	Height 12 mm	In distribution
42-5122-003-16	Height 16 mm	In distribution
42-5221-007-13	CR Femur Sizes 6-7	In distribution
42-5124-006-11	Height 11 mm	In distribution
42-5124-011-11	Height 11 mm	In distribution
42-5121-005-20	Height 20 mm	In distribution
42-5221-002-14	Height 14 mm	In distribution
42-5221-009-13	Height 13 mm	In distribution
42-5121-005-16	CR Femur Sizes 8-9	In distribution
42-5226-008-11	Height 11 mm	In distribution
42-5122-006-20	Height 20 mm	In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Persona®	Zimmer, Inc.	552
DJO Surgical	Encore Medical, L.P.	415
Genflex2 Total Knee System	Globus Medical, Inc.	389
Truliant, Activit-E	Exactech, Inc.	272
TriVerse Meniscal Insert PS	Signature Orthopaedics PTY Limited	220
U2™ Knee	United Orthopedic Corp.	195
BKS E-Vitalize	Ortho Development Corp.	193
Vanguard XP Instrumentation	Biomet Orthopedics	169
Attune	Depuy (Ireland)	161
Vanguard Complete Knee System	Biomet Orthopedics	153
EXp Tibial Inserts and Patellar Components	Globus Medical, Inc.	144
TriVerse Meniscal Insert AS	Signature Orthopaedics PTY Limited	126

Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Recalls Naming This Product

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

Recalls naming the identifiers of Persona® Vivacit-E®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Zimmer, Inc.	510(k) number	2016-05-11	Class II	Component design/selection	Zimmer Inc. is initiating a recall of specific Persona” Trabecular Metal” Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.	10,256	2017-06-02
Zimmer, Inc.	510(k) number	2015-01-28	Class II	Under Investigation by firm	An increase in complaints of loosening and radiolucent lines.	11,658	2018-03-13
Zimmer, Inc.	510(k) number	2014-12-11	Class II	Device Design	Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and i	67963	2015-10-23
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 units total	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 units total	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2014-08-07	Class II	Device Design	Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument	77,737 total units	2015-01-27
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11
Zimmer, Inc.	510(k) number	2013-06-10	Class II	Device Design	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs.	70,986 distribution events	2014-09-11

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.