FDA.reportPublic FDA data

COPAL® knee moulds

Primary DI
04260102139237
Brand
COPAL® knee moulds
Company
Heraeus Medical GmbH
Model
S
Catalog number
5159868
Device description
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision.COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is preventedCOPAL® knee moulds are intended for single use and must not be re-used or resterilised.
Published
2023-04-21
Public version status
New
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222570000COPAL knee mouldsHeraeus Medical GmbH2023-02-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260102139244PackageGS11In Commercial Distribution
04260102139251PackageGS164In Commercial Distribution
04260102139237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260102139244042601021392444260102139244
04260102139251042601021392514260102139251
04260102139237042601021392374260102139237

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacer mouldA moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260102131170PALAMIX®Cement gun660361632018-03-19
04260102133044COPAL® exchange GTrial Set knee50926072020-07-07
04260102139329COPAL® knee mould Trial M USM51659232023-06-25
04260102139350COPAL® knee mould Trial L USL51659242023-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20