FDA.reportPublic FDA data

COPAL® knee mould Trial L US

Primary DI
04260102139350
Brand
COPAL® knee mould Trial L US
Company
Heraeus Medical GmbH
Model
L
Catalog number
5165924
Device description
COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
Published
2023-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260102139367PackageGS115In Commercial Distribution
04260102139374PackageGS1270In Commercial Distribution
04260102139350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260102139367042601021393674260102139367
04260102139374042601021393744260102139374
04260102139350042601021393504260102139350

GMDN Terms#

Term, Definition table
TermDefinition
Knee revision femur/tibia prosthesis trialA copy of a final knee revision prosthesis, in the form of combined femoral and tibial components, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device.

Regulatory Flags#

DUNS number
333623937
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260102133044COPAL® exchange GTrial Set knee50926072020-07-07
04260102139329COPAL® knee mould Trial M USM51659232023-06-25
04260102139381COPAL® knee mould Trial S USS51598742023-06-25
04260102139411OSTEOPAL®V51309822025-09-26
04260102139428OSTEOPAL®V51309822025-09-26
04260102139855COPAL® G+V1x4051842672024-06-10
04260102139862COPAL® G+V1x4051842672024-06-10
04260102136670COPAL® exchange Ghip S long50347922019-11-25
04260102136700COPAL® exchange Ghip M long50347902019-11-25
04260102136731COPAL® exchange G hip L long50347852019-11-25
04260102136762COPAL® exchange Ghip XL long50347942019-11-25
04260102136793COPAL® exchange Ghip S short50347932019-11-25
04260102136823COPAL® exchange Ghip M short50347912019-11-25
04260102136854COPAL® exchange Ghip L short50347882019-11-25
04260102139176COPAL® exchange Ghip S medium51472152022-05-15
04260102139206COPAL® exchange Ghip M medium51472162022-05-15
04260102136885COPAL® exchange Ghip XL short50347952019-11-25
04260102136694COPAL® exchange Ghip S long50347922019-11-25
04260102136724COPAL® exchange Ghip M long50347902019-11-25
04260102136755COPAL® exchange G hip L long50347852019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
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00885556841549XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841556XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
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00885556841655XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841662XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841679XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841686XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841693XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841709XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841716XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841723XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841730XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02