(283 days)
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No
The summary describes a traditional knee implant system and its mechanical performance testing, with no mention of AI or ML capabilities.
Yes
The device, a unicompartmental knee system, is indicated for restoring a knee affected by various conditions like osteoarthritis and fractures, and for revision procedures, which are directly aimed at treating or alleviating a medical condition.
No
The provided text describes a unicompartmental knee system for surgical implantation to restore knee function, not for diagnosing medical conditions. It focuses on treatment and revision procedures.
No
The device description clearly outlines physical components made of CoCr and Ti6Al4V, which are materials used in hardware implants. The performance studies also focus on the mechanical properties of these physical components.
Based on the provided information, the NanoOrtho NanoKnee® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- NanoOrtho NanoKnee® System Description: The description clearly states that this is a unicompartmental knee system intended for implantation to restore a damaged knee joint. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use describes the conditions the device is used to treat within the knee joint itself, not for diagnostic purposes using bodily fluids or tissues.
Therefore, the NanoOrtho NanoKnee® System falls under the category of a medical device (specifically, an orthopedic implant), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:
-
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- Correction of femoral deformity;
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- Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX, HRY, NJD
Device Description
The NanoOrtho NanoKnee® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
- Fatigue performance of the tibial tray (ASTM F3140-17)
- o Interlock mechanism strength of the tibial tray and insert (ASTM F2083-12)
- o Tibiofemoral contact area and stress (ASTM F2083-12)
- Tibiofemoral constraint (ASTM F1223-14)
- o Range of motion (ASTM F2083-12)
Key Results: The results confirm that all components of the NanoOrtho NanoKnee® System are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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December 20, 2019
NanoOrtho, LLC Andy Rynearson Vice President Quality & Regulatory 860 Oak Park Blvd STE 301 Arroyo Grande, California 93420
Re: K190633
Trade/Device Name: NanoOrtho NanoKnee® 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, HRY, NJD Dated: November 19, 2019 Received: November 20, 2019
Dear Andy Rynearson:
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
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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 Acting 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)
K190633
Device Name NanoOrtho NanoKnee® System
Indications for Use (Describe)
The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:
-
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- Correction of femoral deformity;
-
- Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without 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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6. 510(k) Summary
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
6.1 510(k) Owner and Registration
| Owner's Name: | NanoOrtho, LLC. |
|---|---|
| Address: | 860 Oak Park Blvd., Ste 301, Arroyo Grande, CA 93420 |
| Phone Number: | (805) 714-8984 |
| Fax Number: | (855) 710-7338 |
| Date Summary Prepared: | March 8, 2019 |
| Establishment Registration Number: | N/A |
6.2 510(k) Contact
| Contact: | Andy Rynearson |
|---|---|
| Address: | 860 Oak Park Blvd., Ste 301, Arroyo Grande, CA 93420 |
| Phone Number: | (321) 316-2601 |
| Fax Number: | (855) 710-7338 |
| Contact Person: | Andy Rynearson |
6.3 Device Name and Classification
| Device Trade Name: | NanoOrtho NanoKnee® System |
|---|---|
| Device Common Name: | Unicondylar Knee |
| Regulation Number and Description: | 21 CFR 888.3520 |
| Device Class: | Class II |
| Product Codes: | HSX, HRY, NJD |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate 6.4
NanoOrtho is utilizing the Smith & Nephew Journey Unicondylar Knee System (K073175) as the primary predicate device. Additionally, NanoOrtho is utilizing the Mako Restoris Porous Partial Knee System (K133811) as a predicate device. The NanoKnee® System features component designs, materials, indications, and manufacturing methods that are substantially equivalent to the predicate device systems.
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Device Description 6.5
The NanoOrtho NanoKne® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.
6.6 Intended Use
The NanoOrtho NanoKnee® System indications for use are similar to the predicate Mako Restoris Porous Partial Knee System (K133811) & Smith & Nephew Journey Unicondylar Knee System (K073175).
The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:
-
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic
arthritis, or avascular necrosis;
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic
-
- Correction of femoral deformity;
-
- Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
The NanoOrtho NanoKnee® System is designed for single use and are intended for implantation with or without bone cement.
Summary of Technological Characteristics 6.7
The NanoOrtho NanoKnee® system is similar to the predicate Mako Restoris Porous Partial Knee System (K133811) & Smith & Nephew Journey Unicondylar Knee System (K073175). These devices are manufactured from the same materials, possess the same size ranges. Extensive preclinical testing was performed on the NanoOrtho NanoKnee® system and found substantially equivalent to the predicate devices. The performance tests are listed below and used herein to establish substantial equivalence (Section 19 Performance Testing – Bench)
6.8 Performance Testing
The results confirm that all components of the NanoOrtho NanoKnee® System are substantially equivalent to the predicate devices.
- Fatigue performance of the tibial tray (ASTM F3140-17)
- o Interlock mechanism strength of the tibial tray and insert (ASTM F2083-12)
- o Tibiofemoral contact area and stress (ASTM F2083-12)
- Tibiofemoral constraint (ASTM F1223-14)
- o Range of motion (ASTM F2083-12)
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6.9 Conclusions
The NanoOrtho NanoKnee® System has similar design features, materials, and indications for use as the predicate devices.
The NanoOrtho NanoKnee® System is equivalent to the predicate devices.