← Product Code [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX) · K203341 # ACS LD Uni FB Knee System (K203341) _Implantcast GmbH · HSX · Jan 8, 2021 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203341 ## Device Facts - **Applicant:** Implantcast GmbH - **Product Code:** [HSX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX.md) - **Decision Date:** Jan 8, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3520 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is single-use implant intended for implantation with bone cement. ## Device Story ACS® LD Uni FB Knee System is a unicondylar knee replacement implant. Components include femoral component, tibial component, and polyethylene (PE) insert. Device is single-use and requires bone cement for fixation. Used by orthopedic surgeons in clinical settings for patients with unicompartmental osteoarthritis and intact ligaments. Device replaces articulating surfaces of knee joint to restore function and reduce pain associated with degenerative disease or trauma. ## Clinical Evidence Bench testing only. Performance characterized via constraint testing (ASTM F1223), contact area/stress analysis (ASTM F2083), fatigue testing (ASTM F3140-17), and interlocking strength testing (ASTM F2083, ASTM F1814). ## Technological Characteristics Unicondylar knee prosthesis consisting of femoral, tibial, and PE-insert components. Materials include metal and polymer. Testing conducted per ASTM F1223 (constraint), ASTM F2083 (contact area/stress, interlocking), ASTM F1814 (interlocking), and ASTM F3140-17 (fatigue). Cemented fixation. ## Regulatory Identification A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027). ## Predicate Devices - Biomet Repicci II® Unicondylar Knee ([K063515](/device/K063515.md)) - Bodycad Unicompartmental Knee System ([K163700](/device/K163700.md), [K181302](/device/K181302.md)) - Medacta GMK® UNI ([K161741](/device/K161741.md)) - Zimmer Unicompartmental Knee System ([K033363](/device/K033363.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ January 8, 2021 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Implantcast GmbH % Dave McGurl Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001 Re: K203341 Trade/Device Name: ACS® LD Uni FB Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: November 12, 2020 Received: November 12, 2020 Dear Dave McGurl: 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 {1}------------------------------------------------ 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 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203341 Device Name ACS® LD Uni FB Knee System #### Indications for Use (Describe) The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is single-use implant intended for implantation with bone cement. 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." {3}------------------------------------------------ # 5. 510(K) SUMMARY | Device Trade Name: | ACS® LD Uni FB Knee System | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | implantcast, GmbH
Lüneburger Schanze 26
2164 Buxtehude, Germany | | Contact: | Ms. Juliane Höppner
Head of Regulatory Affairs
Phone: +49 4161 744 135
Email: jhoppener@mcra.com | | Prepared by: | Mr. Dave McGurl
Director, Regulatory Affairs
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20005
Phone: 202.552.5800
dmcgurl@mcra.com | | Date Prepared: | August 24, 2020 | | Classification: | 21 CFR §888.3520, Knee joint femorotibial metal/polymer non-
constrained cemented prosthesis | | Class: | II | | Product Code: | HSX | | Predicate Devices: | Biomet Repicci II® Unicondylar Knee (K063515)
Bodycad Unicompartmental Knee System (K163700, K181302)
Medacta GMK® UNI (K161741)
Zimmer Unicompartmental Knee System (K033363) | ## Indications for Use: The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is single-use implant intended for implantation with bone cement. # Device Description: The ACS® LD Uni FB Knee System is a unicondylar knee replacement system. It is intended for patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments. {4}------------------------------------------------ The ACS® LD Uni FB Knee System consists of the following components: - ACS® Uni LD Femoral Component . - Uni FB Tibial Component ● - Uni FB PE-Insert ● # Substantial Equivalence: The ACS® LD Uni FB Knee System is substantially equivalent to the predicate devices cited with respect to intended use, design, and materials. # Performance Testing: All recommended testing has been performed for the worst-case configuration of the ACS® LD Uni FB Knee System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the ACS® LD Uni FB Knee System was characterized through the following tests: - Constraint Testing (ASTM F1223) - o Medial-lateral and anterior-posterior displacement, rotary-laxity rotation - Contact Area / Stress (ASTM F2083) - Fatigue Testing Tibia (ASTM F3140-17) ● - o Interlocking Strength (ASTM F2083, ASTM F1814) - O Anterior-posterior, posterior-anterior, medial-lateral-medial - o Range of motion evaluation ## Conclusion: The ACS® LD Uni FB Knee System possesses the same intended use and technological characteristics as the predicate devices. Therefore, the ACS® LD Uni FB Knee System is substantially equivalent for its intended use. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203341](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203341) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com