COPAL® exchange G
- Primary DI
- 04260102136694
- Brand
- COPAL® exchange G
- Company
- Heraeus Medical GmbH
- Model
- hip S long
- Catalog number
- 5034792
- Device description
- The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
- Published
- 2019-11-25
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K191016 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260102136687 | Package | GS1 | 12 | In Commercial Distribution |
| 04260102136694 | Package | GS1 | 144 | In Commercial Distribution |
| 04260102136670 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260102136687 | 04260102136687 | 4260102136687 |
| 04260102136694 | 04260102136694 | 4260102136694 |
| 04260102136670 | 04260102136670 | 4260102136670 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic cement spacer | A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 333623937
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04260102133044 | COPAL® exchange G | Trial Set knee | 5092607 | 2020-07-07 |
| 04260102139329 | COPAL® knee mould Trial M US | M | 5165923 | 2023-06-25 |
| 04260102139350 | COPAL® knee mould Trial L US | L | 5165924 | 2023-06-25 |
| 04260102139381 | COPAL® knee mould Trial S US | S | 5159874 | 2023-06-25 |
| 04260102139411 | OSTEOPAL® | V | 5130982 | 2025-09-26 |
| 04260102139428 | OSTEOPAL® | V | 5130982 | 2025-09-26 |
| 04260102139855 | COPAL® G+V | 1x40 | 5184267 | 2024-06-10 |
| 04260102139862 | COPAL® G+V | 1x40 | 5184267 | 2024-06-10 |
| 04260102136670 | COPAL® exchange G | hip S long | 5034792 | 2019-11-25 |
| 04260102136700 | COPAL® exchange G | hip M long | 5034790 | 2019-11-25 |
| 04260102136731 | COPAL® exchange G | hip L long | 5034785 | 2019-11-25 |
| 04260102136762 | COPAL® exchange G | hip XL long | 5034794 | 2019-11-25 |
| 04260102136793 | COPAL® exchange G | hip S short | 5034793 | 2019-11-25 |
| 04260102136823 | COPAL® exchange G | hip M short | 5034791 | 2019-11-25 |
| 04260102136854 | COPAL® exchange G | hip L short | 5034788 | 2019-11-25 |
| 04260102139176 | COPAL® exchange G | hip S medium | 5147215 | 2022-05-15 |
| 04260102139206 | COPAL® exchange G | hip M medium | 5147216 | 2022-05-15 |
| 04260102136885 | COPAL® exchange G | hip XL short | 5034795 | 2019-11-25 |
| 04260102136724 | COPAL® exchange G | hip M long | 5034790 | 2019-11-25 |
| 04260102136755 | COPAL® exchange G | hip L long | 5034785 | 2019-11-25 |
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