(57 days)
Not Found
No
The summary describes a mechanical implant for knee replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are standard mechanical tests for implants.
Yes
The device is a knee replacement system intended for partial replacement of articulating surfaces of the knee, which is a therapeutic intervention for degenerative diseases or fractures.
No
The device description clearly states it is a "single-use implant intended for implantation with bone cement" and a "unicondylar knee replacement system," indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "unicondylar knee replacement system" consisting of physical components (femoral component, tibial component, PE-insert), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant for the partial replacement of knee joint surfaces. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details physical components (femoral component, tibial component, PE-insert) that are implanted into the body.
- Performance Studies: The performance studies listed are related to the mechanical properties and durability of the implant (constraint testing, contact area/stress, fatigue testing), not diagnostic performance.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HSX
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.
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Biomet Repicci II® Unicondylar Knee (K063515), Bodycad Unicompartmental Knee System (K163700, K181302), Medacta GMK® UNI (K161741), Zimmer Unicompartmental Knee System (K033363)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
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
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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) |
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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.