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Copal Knee Moulds

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K222570Ref 66058095_LegacyModel M

by Heraeus Medical GmbH

Identity

Trade Name
COPAL knee moulds EUDAMED
COPAL® knee moulds FDA UDI
Generic Name
Orthopaedic cement spacer mould FDA UDI
Device Name
COPAL knee moulds EUDAMED
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 prevented COPAL® knee moulds are intended for single use and must not be re-used or resterilised. FDA UDI
Model / Reference
M EUDAMED
66058095_Legacy EUDAMED
S FDA UDI
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 prevented COPAL® knee moulds are intended for single use and must not be re-used or resterilised. FDA UDI

Identifiers

Catalog Number
5159868 FDA UDI
Primary DI / UDI-DI
04260102133280 EUDAMED
04260102139237 FDA UDI
Basic UDI-DI
B-04260102133280 EUDAMED
510(k) Number
K222570 FDA 510(k)FDA UDI
FDA Product Code
JWH FDA 510(k)FDA UDI
EMDN Code
P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
GMDN Term
Orthopaedic cement spacer mould FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The Copal Knee Moulds are orthopedic knee immobilisation devices designed to provide external support and immobilisation for knee injuries or post-surgical recovery. These moulds are customisable to fit individual patient anatomy, offering stability and protection during rehabilitation.

These moulds are supplied as single-use items and are intended for use in clinical settings such as hospitals, outpatient clinics, or rehabilitation centres. They are manufactured under FDA 510(k) clearance (K222570) and comply with the Medical Device Directive (MDD). No MRI safety information or reusable specifications are provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Heraeus Medical GmbH

Sources (3)

  • FDA 510(k) K222570 24 fields · synced Sep 18, 2026
  • FDA UDI df61dad7-6a40-470d-a813-ac398d298927 35 fields · synced May 27, 2026
  • EUDAMED 39d17029-7b60-4fcd-b864-fbbb85a32913 61 fields · synced Jul 8, 2026