COPAL knee moulds

K222570 · Heraeus Medical GmbH · JWH · Feb 4, 2023 · Orthopedic

Device Facts

• Record ID: K222570
• Device Name: COPAL knee moulds
• Applicant: Heraeus Medical GmbH
• Product Code: JWH · Orthopedic
• Decision Date: Feb 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer molds indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Device Story

COPAL® knee moulds are sterile, single-use molds used by surgeons to create temporary knee spacers; molds are filled with PALACOS® R+G bone cement (PMMA with antibiotic). The resulting spacer maintains joint space and alignment; prevents soft tissue contraction; provides limited mobility/partial weight-bearing during infection treatment. Used in two-stage septic joint revision procedures. The spacer is implanted for up to 180 days; removed after infection resolution. Benefits include patient comfort and preservation of anatomical space during the interval between prosthesis removal and permanent reimplantation.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), mechanical/functional testing, and sterilization validation (ISO 11135).

Technological Characteristics

Sterile, single-use molds for tibial and femoral components. Material: unspecified polymer. Sterilization: Ethylene oxide (ISO 11135). Designed for use with PALACOS® R+G PMMA antibiotic bone cement. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing a two-stage revision procedure for a septic process requiring a temporary total knee replacement (TKR) for up to 180 days. Contraindicated for patients unable to consistently use traditional mobility assist devices (e.g., crutches, walkers).

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Tecres Spacer-K (K032522)

Submission Summary (Full Text)

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February 4, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.

Heraeus Medical GmbH Alexander Peczka Senior Manager Regulatory Affairs Philipp-Reis-Str. 8/13 Wehrheim, Hessen 61273 Germany

Re: K222570

Trade/Device Name: COPAL® knee moulds Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 23, 2022 Received: August 23, 2022

Dear Mr. Peczka:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Sara S. Thompson -S

For

Laura C. Rose, 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

Enclosure

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# Indications for Use

510(k) Number (if known) K222570

Device Name COPAL® knee moulds

## Indications for Use (Describe)

COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a large, bold, sans-serif font in gray color. Below the word "Heraeus", the words "Heraeus Medical GmbH" are written in a smaller, bold, sans-serif font in black color.

# 510(k) Summary - K222570

| I. SUBMITTER | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Heraeus Medical GmbH<br>Philipp-Reis-Str. 8/13<br>61273 Wehrheim<br>Germany |
| Contact Person: | Alexander Peczka<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Additional Contact Person: | Benjamin Hagedorn<br>Head of Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | August, 12th 2022 |
| II. DEVICES | |
| Name of Device: | COPAL® knee moulds |
| Common Name: | Knee moulds |
| Classification Name: | Knee joint polymer cemented prosthesis (21 CFR 888.3560) |
| Regulatory Class: | Class II |
| Product Code: | JWH |
| Subsequent Product Code(s): | Not applicable |

## III. PREDICATE DEVICES

Tecres Spacer-K (K032522)

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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in large, gray, sans-serif font on the top line. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH".

A Traditional 510(k) submission is being supplied to the U.S. FDA to qain clearance to market for COPAL® knee moulds

### IV. DEVICE DESCRIPTION / INTENDED USE

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 aqainst 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.

#### VI. INDICATIONS FOR USE

COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer molds indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The spacer molded by the Heraeus COPAL® knee moulds are substantially equivalent to the knee spacer of the cleared predicate device (K032522) with respect to the following:

The intended use is equivalent in that they are both indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The proposed and predicate devices are intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The technological characteristics of the spacers formed by the Heraeus COPAL® knee moulds and the predicate product are identical in that they are all designed to mimic a permanent implant for a period of up to 180 days. The configurations consist of knee components that mimic the intended anatomical space. The knee spacers formed by the Heraeus COPAL® knee moulds are also used to be molded with PALACOS® R+G a PMMA antibiotic bone cement as also the predicate devices contain an antibiotic component that helps to facilitate the healing process. There are no major differences between the proposed and the predicate devices and are substantial equivalent in materials and design.

The operational characteristics of the spacers formed by the Heraeus COPAL® knee moulds are equivalent to the predicate device. The basic operational principle for the predicate device, as well

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Image /page/5/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font in gray. Below it, in a smaller, bold, sans-serif font, are the words "Heraeus Medical GmbH" in black.

as the subject device is for temporary use (maximum of 180 days) as a TKR in skeletally mature patients undergoing a two-stage procedure due to a septic process. The method of insertion and the operative technique is identical for both subject device and predicate device.

Both Spacers provide patients, undergoing a two stage revision procedure for an infected total joint, a temporary implant to allow for partial weight bearing.

The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin released from the bone cement protects the spacer from bacterial colonization.

The spacers formed by the Heraeus COPAL® knee moulds and the predicate devices 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 spacers formed by the COPAL® knee moulds and the predicate spacers are made with bone cement.

The proposed and predicate devices are provided in a range of sizes that are compatible with skeletally mature adults.

All of these technological characteristics are equal fit, form and function resulting in the spacers formed by the Heraeus COPAL® knee moulds are being substantially equivalent to the Tecres Spacer-K.

#### PERFORMANCE DATA VIII.

Testing was conducted according to the FDA recognized standards in order to demonstrate equivalence to the predicate devices.

# Biocompatibility testing

A biocompatibility evaluation for COPAL® knee moulds was conducted in accordance with the 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 (FDA 2020)" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation .
- . Material-mediated Pvrogenicitv
- . Acute Systemic Toxicity

COPAL® knee moulds are categorized as: externally communicating medical device with indirect / direct contact to tissue / bone for limited (≤ 24 hours) contact duration.

# Mechanical and functional testing

These tests include Mechanical tests as well as Wear tests and demonstrates that spacers formed by the COPAL® knee moulds are mechanically and functionally similar to the predicate devices. The verification and validation testing performed demonstrated that COPAL® knee moulds function as intended and are safe and effective for their use.

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Image /page/6/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font and is gray in color. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, bold, sans-serif font and is black in color. The logo is simple and modern.

# Sterilization

Validation of the sterilization was performed in accordance to ISO 11135. The sterilization is carried out by gassing with ethylene oxide. The sterilization cycle is designed to deliver sterile units, starting with a defined bioburden and ending with a sterility assurance level (SAL) of 10°. Based on the tests performed and the results obtained, the chosen sterilization process can be considered as valid.

The COPAL® knee moulds meet the requirements of FDA Guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (January 21, 2016).

# Pyrogenicity

N/A - Pyrogenicity testing was not performed for COPAL® knee moulds because the determination of bacterial endotoxins is only required for sterile implantable medical devices that contact nonintact tissue during use or medical devices that have direct intravascular, intralymphatic, intrathecal, and/or intraocular contact.

In summary, the verification and validation testing performed demonstrate that the Heraeus COPAL® knee moulds function as intended and are safe and effective for their intended use and where appropriate were tested and found to be substantially equivalent to the predicate devices.

#### CLINICAL TESTING IX.

No clinical testing was performed

#### X. CONCLUSIONS

The spacers formed by the Heraeus COPAL® knee moulds have been shown to be substantially equivalent to the predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance testing. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices and demonstrates them to be substantial equivalent.