(84 days)
This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
This product 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.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities.
With pre-clinical validations of antibiotic elution, tibial spacer fatigue test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.
Cellbrick Knee Spacer is a temporary knee spacer product, it's suitable for the patients with mature skeleton and required to perform two-stage knee joint prosthesis procedure for infection control. It consists of three components, which are (1) Femoral Spacer, (2) Tibial Spacer, and (3) Canal Rod. The Femoral Spacers and the Tibial Spacers are designed with multiaperture features, which can act as carrier of antibiotic-loaded bone cement to release antibiotic at infection site. The Canal Rod is optional.
- Femoral Spacer
The Femoral Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The geometrical appearance of Femoral Spacer is designed and modified based on the 510(k) cleared cruciate-retaining femoral component (K140073). Their articular surface geometry and curvature is identical. In addition, the Femoral Spacer is designed with multiaperture feature. Such scaffold-like features can use as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
The Femoral Spacer can be used for both of left and right knee because of the symmetric condyle design. Five femoral spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions. The Femoral Spacer is designed “same/ one up" sizing options with the tibial spacers. - Tibial Spacer
The Tibial Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The bearing surface's curvature and geometrical design of the tibial spacer is the same as the 510(k) cleared ultra-congruent tibial insert (K132752, K150829, and K222700). The Tibial Spacer is designed with multiaperture feature as well. This scaffold-like feature is used as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
Five Tibial Spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions. - Canal Rod
The canal rod is made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3). As a carrier, the rod provides the area for cement to attach so that to increase the surface area of cement. The canal rod is an optional device, it could be applied to patient with deeper infection problem, applying Canal Rod can make surgeon placing antibiotic-loaded cement into the deeper infection site. The Canal Rod is provided with one dimension: Ø 4(diameter) ×80mm (length).
The provided text is a 510(k) summary for the "Cellbrick Knee Spacer". It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.
The requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is all highly relevant to the evaluation of AI/ML-driven medical devices. Since the Cellbrick Knee Spacer is described as a physical implant (femoral spacer, tibial spacer, canal rod made of UHMWPE and Ti-6Al-4V alloy) and not a software or AI/ML product, the submission details focus on pre-clinical validations for physical properties like antibiotic elution, wear tests, fatigue tests, range of motion, constraint performance, and endotoxin testing.
Therefore, I cannot provide the requested information as it is not present in the provided document. The document describes a physical medical device clearance, not an AI/ML device validation.
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Image /page/0/Picture/0 description: The image shows the date December 20, 2024. The text is written in a clear, sans-serif font. The date is written in a standard format, with the month, day, and year clearly indicated. The image is simple and straightforward, with the focus on the date itself.
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 Taiwan
Re: K243024
Trade/Device Name: Cellbrick Knee Spacer Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 13, 2024 Received: September 27, 2024
Dear Lois Ho:
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"
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(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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely, JESSE MUIR - Digitally signed by JESSE
MUIR - MUIR - MUIR -s mo
Date: 2024.12.20 16:14:33
-05'00' S Jesse Muir, PhD
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) K243024
Device Name Cellbrick Knee Spacer
Indications for Use (Describe)
This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
This product 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.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities. With pre-clinical validations of antibiotic elution, tibial spacer wear test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green letter U with a white circle inside of it. To the right of the U is the text "UNITED ORTHOPEDIC" in black, with a registered trademark symbol after the word "ORTHOPEDIC".
510(K) SUMMARY
Traditional 510(k)
[as required by 21 CFR 807.92(c)]
Contact Details
| Applicant Name | United Orthopedic Corporation |
|---|---|
| Applicant Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan |
| Applicant ContactTelephone | +88635773351 |
| Applicant Contact | Mrs. Lois Ho |
| Applicant Contact Email | lois.ho@unitedorthopedic.com |
Device Name
| Device Trade Name | Cellbrick Knee Spacer |
|---|---|
| Common Name | Prosthesis, knee, patellofemorotibial, semi-constrained,cemented, polymer/metal/polymer |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Requlation Number | 888.3560 |
| Product Codes | JWH |
Predicate Device Information
| 510(k) Number | Predicate Trade Name | Product Code |
|---|---|---|
| Primary Predicate | ||
| K222570 | COPAL® knee moulds | JWH |
| Predicate or Reference Devices | ||
| K101356 | Spacer-K | JWH |
| K181732 | Spacer-K | JWH |
| K183017 | REMEDY® Stemmed Knee Spacer | JWH |
| K140073 | U2 Total Knee System | JWH |
| K132752 | U2 Total Knee System | JWH |
| K150829 | U2 Total Knee System | JWH |
| K222700 | U2 Total Knee System | JWH |
| Device Description | Cellbrick Knee Spacer is a temporary knee spacer product, it'ssuitable for the patients with mature skeleton and required toperform two-stage knee joint prosthesis procedure for infectioncontrol. It consists of three components, which are (1) FemoralSpacer, (2) Tibial Spacer, and (3) Canal Rod. The FemoralSpacers and the Tibial Spacers are designed with multiaperturefeatures, which can act as carrier of antibiotic-loaded bone |
|---|---|
| Summary | |
| cement to release antibiotic at infection site. The Canal Rod isoptional.- Femoral SpacerThe Femoral Spacer is made of UHMWPE (ASTMF648/ISO5834-2). The geometrical appearance of FemoralSpacer is designed and modified based on the 510(k) clearedcruciate-retaining femoral component (K140073). Theirarticular surface geometry and curvature is identical. Inaddition, the Femoral Spacer is designed with multiaperturefeature. Such scaffold-like features can use as a carrier ofantibiotic-loaded cement to release antibiotic at the infectionsite for infection control.The Femoral Spacer can be used for both of left and right kneebecause of the symmetric condyle design. Five femoral spacersizes have been prepared for different anatomical demandswith anteroposterior (AP) and mediolateral (ML) dimensions.The Femoral Spacer is designed “same/ one up" sizing optionswith the tibial spacers.- Tibial SpacerThe Tibial Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The bearing surface's curvature and geometrical design ofthe tibial spacer is the same as the 510(k) cleared ultra-congruent tibial insert (K132752, K150829, and K222700). TheTibial Spacer is designed with multiaperture feature as well.This scaffold-like feature is used as a carrier of antibiotic-loaded cement to release antibiotic at the infection site forinfection control.Five Tibial Spacer sizes have been prepared for differentanatomical demands with anteroposterior (AP) andmediolateral (ML) dimensions.- Canal RodThe canal rod is made of Ti-6Al-4V alloy (ASTM F136/ISO5832-3). As a carrier, the rod provides the area for cement toattach so that to increase the surface area of cement. Thecanal rod is an optional device, it could be applied to patientwith deeper infection problem, applying Canal Rod can makesurgeon placing antibiotic-loaded cement into the deeperinfection site. The Canal Rod is provided with one dimension:Ø 4(diameter) ×80mm (length). | |
| Intended Use/Indications for Use | This product is indicated for temporary use (maximum of 180days) as a total knee replacement (TKR) in skeletally maturepatients undergoing a two-stage procedure due to a septicprocess. |
| This product is not intended for use for more than 180 days, atwhich time it must be explanted and a permanent deviceimplanted or another appropriate treatment performed (e.g.,resection arthroplasty, fusion, etc.). During the implantationperiod, patients have to use traditional mobility assist devices(e.g. crutches, walkers, canes) for daily activities.With pre-clinical validations of antibiotic elution, tibial spacerfatigue test, and knee spacer wear test, only Palacos MV+Gbone cement may be used for preparing the spacers. | |
| Indications for UseComparison | The indication for use of the subject device is substantiallyequivalent to the primary predicate.Although the content of indication for use is not completelyidentical, however, both of the subject device and primarypredicate are temporary implants (maximum of 180 days),which is intended to apply for the patient with mature skeletonand required a two-stage procedure due to a septic process. Inaddition, both should use mobility assist devices during theperiod of implantation.Base on above mentioned, the indication for use of subjectdevice is considered as substantially equivalent to the primarypredicate. |
| TechnologicalComparison | The technological characteristics of the subject device aresubstantially equivalent to those of the primary predicate(K222570), as the comparison given below shows.- Their intended use is the same.- The intended users, intended surgical procedure, bodycontact and duration, and fixation method are identical to theprimary predicate.- For the difference in the material, appearance design,specification, device X-ray visibility, and sterilization method,evaluation and verification activities were conducted, and theequivalent safety and effectiveness compared to the predicatedevices were validated.It established that no new risks arise compared to those of thepredicate devices. |
| Non-Clinical and/orClinical Tests Summary& Conclusions | Based on the technological characteristics of the subject device,the following evaluation and tests were conducted to validatethe safety and effectiveness of the subject device.- Fatigue test for Tibial spacer- Range of Motion- Constraint performance on the tibiofemoral interface- Wear test- Antibiotic release test & In vitro antibiotic test- Usability evaluation- Endotoxin testing |
| Not Applicable. | |
| Based upon equivalences in intended use, patient population,site of application, conditions of use, and non-clinicalperformance data, the Subject device has been shown to besafe and effective and to perform equivalently as compared tothe legally marketed predicate devices.Therefore, the Subject device is substantially equivalent to thelegally marketed predicate devices. |
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Image /page/5/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green letter U with a white circle inside, next to the words "UNITED ORTHOPEDIC" in black. The word "ORTHOPEDIC" has a registered trademark symbol next to it.
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Image /page/6/Picture/1 description: The image contains the logo for United Orthopedic. The logo consists of a green letter U with a white circle inside, followed by the words "UNITED ORTHOPEDIC" in black. The word "ORTHOPEDIC" has a registered trademark symbol next to it.
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Image /page/7/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green circle with a white circle inside, resembling the letter 'U'. To the right of the symbol, the words 'UNITED' and 'ORTHOPEDIC' are stacked on top of each other in a simple, sans-serif font. A small registered trademark symbol appears next to the word 'ORTHOPEDIC'.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.