(57 days)
No
The summary describes a physical implant and bone cement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a temporary total hip replacement indicated for use in patients undergoing a two-stage procedure due to a septic process, which is a therapeutic intervention. It also includes gentamicin to reduce bacterial colonization, further supporting its therapeutic role in treating infection.
No
Explanation: The device, COPAL® exchange G hip spacer, is indicated for temporary use as a total hip replacement in a two-stage procedure due to a septic process and is an implant used for treatment, not diagnosis.
No
The device description clearly states it is a physical implant made of polymethylmethacrylate and stainless steel, and it is used in conjunction with bone cement. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The COPAL® exchange G hip spacer and COPAL® G+V bone cement are implantable medical devices used in a surgical procedure to treat a septic process in the hip joint. They are physically inserted into the body.
- Intended Use: The intended use clearly describes a surgical intervention and the temporary replacement of a hip joint, not the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.
Product codes
KWL, KWY, MBB
Device Description
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for a modification to the existing COPAL® exchange G hip spacer previously cleared in K220492. The change includes the addition of bone cement COPAL® G+V to fixation of COPAL® exchange G hip spacer to the host bone.
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.
COPAL® exchange G hip spacer is made of fully formed polymethyImethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methy) methacrylate)-based (PMMA) bone cement, containing gentamicin and vancomycin, designed for fixation of COPAL® exchange G hip spacer to the host bone. COPAL® G+V is intended for single-use and is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral medullary canal and acetabular cavity
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of non-clinical tests
The compatibility extension does not modify the design, manufacturing, packaging, and sterilization of existing COPAL® exchange G hip spacer. Therefore, the reference device COPAL® exchange G hip spacer (previously cleared in K220492) was used to support the biocompatibility, performance, manufacturing, packaging, sterilization, and shelf-life of the hip spacer portion of the 510(k) submission. The non-clinical tests reviewed as part of K191016 and K220492 remain unchanged.
Mechanical testing
Mechanical testing was performed to characterize the PMMA bone cements and to assess the compatibility to hip spacer:
- ISO 5833 testing of PMMA bone cements
- Antibiotic elution kinetic of PMMA bone cements
- Safety and effectiveness assessment of PMMA bone cements
- Compatibility assessment of COPAL® exchange G hip spacer with the PMMA bone cements
- Safety and compatibility of PMMA bone cement in the MR environment.
Clinical evaluation
A clinical evaluation was performed to analyze the existing clinical data of predicate device and legally marketed U.S. devices and to evaluate whether there is sufficient clinical evidence to confirm the clinical safety and performance when using COPAL® exchange G hip spacer with COPAL® G+V according to the manufacturer's instructions for use. It has been demonstrated that the subject device COPAL® exchange G hip spacer in compatibility with COPAL® G+V bone cement performs as intended if used as intended by the manufacturer and no unknown complications that have not yet been described in the instructions for use were found.
Biocompatibility testing
The biocompatibility evaluation of COPAL® G+V was performed according to FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and recognized consensus standard ISO 10993-1. The battery of testing included the following tests:
- Chemical characterization as per ISO 10993-18
- Toxicological assessment as per ISO 10993-17
- Cytotoxicity as per ISO 10993-5
- Sensitization as per ISO 10993-10
- Intracutaneous irritation as per ISO 10993-10
- Systemic toxicity as per ISO 10993-11
- Implantation as per ISO 10993-6
- Hemocompatibility as per ISO 10993-4 and ASTM F756
- Genotoxicity as per ISO 10993-3
It has been demonstrated that the materials of COPAL® G+V are biological safe, and suitable for their intended use.
Packaging, Sterilization and Shelf Life
COPAL® G+V is sterilized using well established sterilization methods and the validations have been performed following international standards and FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". The compatibility between the packaging material and the sterilization process is ensured and the packaging preserves the functionality and safety of COPAL® G+V throughout its declared shelf-life. COPAL® G+V meets endotoxin limits.
The non-clinical tests demonstrated that the subject device is substantially equivalent to the predicate device.
Summary of clinical tests
No clinical tests were performed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906)
Reference Device(s)
COPAL® exchange G hip spacer (K220492)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2024
Heraeus Medical GmbH Heike Gustke Senior Manager Regulatory Affairs Philipp-Reis-Str. 8-13 Wehrheim, Hessen 61273 Germany
Re: K234028
Trade/Device Name: COPAL® exchange G hip spacer; COPAL® G+V Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWL, KWY, MBB Dated: December 18, 2023 Received: December 20, 2023
Dear Heike Gustke:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
12/1, p. 1) and "Providing Wireless Solutions, 510(k) for Software
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
tally signed by Jesse Muir -5 Jesse Muir -S Date: 2024.02.15 21:13:38
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
Submission Number (if known)
K234028
Device Name
COPAL® exchange G hip spacer; COPAL® G+V
Indications for Use (Describe)
COPAL® exchange G hip spacer (polymethy)methacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image displays the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a bold, sans-serif font in gray color. Below it, the text "Heraeus Medical GmbH" is written in a smaller, black, sans-serif font.
510(k) Summary
| I. SUBMITTER | |
|---|---|
| Manufacturer: | Heraeus Medical GmbH |
| Philipp-Reis-Str. 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Contact Person: | Dr. Heike Gustke |
| Senior Manager Regulatory Affairs | |
| Phone: +49 (6181) 35-2942 | |
| Email: heike.gustke@heraeus.com | |
| Date Prepared: | February 12, 2024 |
| II. DEVICES | |
| Name of Device(s): | COPAL® exchange G hip spacer, COPAL® G+V |
| Device Common Name: | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis |
| Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented | |
| prosthesis | |
| Polymethylmethacrylate (PMMA) bone cement | |
| Regulation Number: | 21CFR 888.3360 |
| 21CFR 888.3390 | |
| 21CFR 888.3027 | |
| Device Class: | Class 2 |
| Product Code: | KWL |
| Associated Product Code(s): | KWY, MBB |
lll. PREDICATE DEVICES
Primary Predicate: Reference Device:
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) COPAL® exchange G hip spacer (K220492)
DEVICE DESCRIPTION IV.
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for a modification to the existing COPAL® exchange G hip spacer previously cleared in K220492. The change includes the addition of bone cement COPAL® G+V to fixation of COPAL® exchange G hip spacer to the host bone.
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.
COPAL® exchange G hip spacer is made of fully formed polymethyImethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
5
Image /page/5/Picture/0 description: The image shows the word "Heraeus" in a sans-serif font. The text is a solid gray color. The letters are evenly spaced and appear to be in a bold typeface.
Heraeus Medical GmbH
COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methy) methacrylate)-based (PMMA) bone cement, containing gentamicin and vancomycin, designed for fixation of COPAL® exchange G hip spacer to the host bone. COPAL® G+V is intended for single-use and is supplied sterile.
V. INDICATIONS FOR USE
COPAL® exchange G hip spacer
COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
COPAL® G+V
COPAL® G+V (gentamicin and vancomvcin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.
The subject device (COPAL® exchange G hip spacer, COPAL® G+V) has the same intended use and indications for use in comparison to the predicate device (REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement). The hip spacer is designed for the first stage of a two-stage revision arthroplasty procedure to temporarily (max. 180 days) replace an implant due to an infection of the implant site in the same patient population.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
The subject device (COPAL® exchange G hip spacer. COPAL® G+V) and the predicate device (REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement) have the same technological characteristics (design features (hip spacer with PMMA bone cement), performance, and operational principle). At a high level, the subject device and predicate device are based on the following same technological elements:
Hip spacer
- . Temporary joint prostheses,
- . Preformed antibiotic-loaded PMMA cement spacer with an inner stainless-steel core,
- . Design (length, diameter, and shape), and
- Fixation with PMMA bone cements. .
PMMA bone cement
- Constituents including antibiotics (gentamicin and vancomycin), .
- Designed for fixation of hip spacer to the host bone, .
- . Biocompatibility of materials, and
- Performance characteristics. .
The following technological differences exist between the subject and predicate devices:
Hip spacer
- COPAL® exchange G hip spacer contains gentamicin and the REMEDY PLUS Hip Spacer contains . gentamicin and vancomycin.
- COPAL® exchange G hip spacer can be fixed with PALACOS® bone cement. ●
PMMA bone cement
- Different radio-opacifier and concentrations of antibiotics.
6
Image /page/6/Picture/0 description: The image shows the word "Heraeus" in a bold, sans-serif font. The text is gray and appears to be a logo or brand name. The letters are evenly spaced and the overall design is clean and modern.
Heraeus Medical GmbH
VII. PERFORMANCE DATA
Summary of non-clinical tests
The compatibility extension does not modify the design, manufacturing, packaging, and sterilization of existing COPAL® exchange G hip spacer. Therefore, the reference device COPAL® exchange G hip spacer (previously cleared in K220492) was used to support the biocompatibility, performance, manufacturing, packaging, sterilization, and shelf-life of the hip spacer portion of the 510(k) submission. The non-clinical tests reviewed as part of K191016 and K220492 remain unchanged.
The following performance data were provided in support of the substantial equivalence determination:
Mechanical testing
Mechanical testing was performed to characterize the PMMA bone cements and to assess the compatibility to hip spacer:
- ISO 5833 testing of PMMA bone cements .
- Antibiotic elution kinetic of PMMA bone cements
- Safety and effectiveness assessment of PMMA bone cements .
- Compatibility assessment of COPAL® exchange G hip spacer with the PMMA bone cements ●
- Safety and compatibility of PMMA bone cement in the MR environment. ●
Clinical evaluation
A clinical evaluation was performed to analyze the existing clinical data of predicate device and legally marketed U.S. devices and to evaluate whether there is sufficient clinical evidence to confirm the clinical safety and performance when using COPAL® exchange G hip spacer with COPAL® G+V according to the manufacturer's instructions for use. It has been demonstrated that the subject device COPAL® exchange G hip spacer in compatibility with COPAL® G+V bone cement performs as intended if used as intended by the manufacturer and no unknown complications that have not yet been described in the instructions for use were found.
Biocompatibility testing
The biocompatibility evaluation of COPAL® G+V was performed according to FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and recognized consensus standard ISO 10993-1. The battery of testing included the following tests:
- Chemical characterization as per ISO 10993-18 ●
- Toxicological assessment as per ISO 10993-17 ●
- Cytotoxicity as per ISO 10993-5 ●
- . Sensitization as per ISO 10993-10
- Intracutaneous irritation as per ISO 10993-10 ●
- Systemic toxicity as per ISO 10993-11 ●
- . Implantation as per ISO 10993-6
- Hemocompatibility as per ISO 10993-4 and ASTM F756 .
- Genotoxicity as per ISO 10993-3 ●
It has been demonstrated that the materials of COPAL® G+V are biological safe, and suitable for their intended use.
Packaging, Sterilization and Shelf Life
COPAL® G+V is sterilized using well established sterilization methods and the validations have been performed following international standards and FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". The compatibility between the packaging material and the sterilization process is ensured and the packaging preserves the functionality and safety of COPAL® G+V throughout its declared shelf-life. COPAL® G+V meets endotoxin limits.
7
Image /page/7/Picture/0 description: The image shows the word "Heraeus" in a gray, sans-serif font. The letters are evenly spaced and appear to be a bold typeface. The word is the main focus of the image and is presented against a white background.
Heraeus Medical GmbH
The non-clinical tests demonstrated that the subject device is substantially equivalent to the predicate device.
Summary of clinical tests
No clinical tests were performed to demonstrate substantial equivalence.
VIII. CONCLUSION
There have been no modifications made to the intended use, design, biocompatibility, materials, sterilization, or packaging of the existing COPAL® exchange G hip spacer. Non-clinical tests have been demonstrated that COPAL® G+V is intended for fixation of COPAL® exchange G hip spacer to the host bone.
COPAL® exchange G hip spacer and COPAL® G+V are substantially equivalent to the predicate device (REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906)) identified in this premarket notification.