(67 days)
No
The document describes a mechanical implant (patella component for knee replacement) and its materials and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee implant intended to resurface the patella (kneecap) during Total Knee Arthroplasty (TKR) to alleviate pain and restore joint function due to disabling knee diseases. This directly addresses health conditions and is used for treatment, rehabilitation, or prevention of disease.
No
This device is a prosthetic implant (patella) used in total knee arthroplasty, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made from UHMWPE and titanium, designed for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant for surgical use in Total Knee Arthroplasty (TKR). This is a surgical procedure performed on a patient's body.
- Device Description: The description details a physical implant made of UHMWPE and titanium, designed to be surgically placed in the knee.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from a patient, not to be implanted within the patient's body.
N/A
Intended Use / Indications for Use
The Optimotion Implants Porous Metal-Backed Patella is intended or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic loss of knee joint configurations and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.
- · Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
- · Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.
Product codes
MBH, JWH, OIY
Device Description
The Optimotion Implants Porous Metal-Backed Patella is an extension of The Optimotion™ Blue Total Knee System (K191084) product line for use in primary Total Knee arthroplasty. The Optimotion Porous Metal-Backed Patella will come in two variations Onset styles. It is a sterile, single use, non-modular porous metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in a symmetric design that is available in multiple sizes. The metal backing features an additive manufactured porous posterior surface and three additive manufactured porous pegs to provide cemented or cementless fixation to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, patella, distal femur, proximal tibia
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)
Performance testing of the Optimotion™ Blue Total Knee System (K191084) was performed per the FDA "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA", consultations with professionals at testing centers, Optimotion™ Implants' surgeon advisors, and engineering consultants. The Optimotion Implants Porous Metal-Backed Patella utilizes the same additive manufacture and processes as the currently cleared Optimotion™ Blue Total Knee System (K191084). The testing included:
- Additive Titanium Porous Structure
- Percent Porosity and Average Pore Size
- Shear Static and Fatigue
Key results: The subject device has similar design features, materials, and indications for use as the predicate devices. The testing performed for the predicate device indicates that the Optimotion Implants Porous Metal-Backed Patella is safe for clinical use.
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.
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.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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March 14, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle and text encircling it. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Optimotion Implants, LLC Andy Rynearson CEO 6052 Turkey Lake Road Orlando, Florida 32819
Re: K220049
Trade/Device Name: Optimotion Implants Porous Metal-Backed Patella Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OIY Dated: January 4, 2022 Received: January 6, 2022
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
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. 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) K220049
Device Name
Optimotion Implants Porous Metal-Backed Patella
Indications for Use (Describe)
The Optimotion Implants Porous Metal-Backed Patella is intended or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic loss of knee joint configurations and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.
- · Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
- · Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.
| 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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3
Premarket Notification:
Optimotion Implants Porous Metal-Backed Patella
510(k) Summary 6.
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
6.1 510(k) Owner and Registration
| Owner's Name: | Optimotion Implants, LLC. |
|---|---|
| Address: | 6052 Turkey Lake Rd, Suite 170 |
| Orlando, FL 32819 | |
| Phone Number: | (321) 316-2601 |
| Fax Number: | N/A |
| Date Summary Prepared: | January 4, 2022 |
| Establishment Registration Number: | N/A |
6.2 510(k) Contact
| Contact: | Andy Rynearson |
|---|---|
| Address: | 6052 Turkey Lake Rd, Suite 170 |
| Orlando, FL 32819 | |
| Phone Number: | (321) 316-2601 |
| Fax Number: | N/A |
| Contact Person: | Andy Rynearson |
Device Name and Classification 6.3
| Device Trade Name: | Optimotion Implants Porous Metal-Backed Patella |
|---|---|
| Device Common Name: | Total Knee Joint Replacement |
| Regulation Number and Description: | 21 CFR 888.3560, 21 CFR 888.3565 |
| Device Class: | Class II |
| Product Codes: | MBH, JWH, OIY |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate 6.4
Optimotion Implants is utilizing the Stryker Triathlon™ Metal-Backed Patella (K132624) as the predicate device. The Optimotion Implants Porous Metal-Backed Patella features component designs, materials, indications, and manufacturing methods that are similar to the Stryker Triathlon™ Metal-Backed Patella.
4
Premarket Notification:
Optimotion Implants Porous Metal-Backed Patella
6.5 Device Description
The Optimotion Implants Porous Metal-Backed Patella is an extension of The Optimotion™ Blue Total Knee System (K191084) product line for use in primary Total Knee arthroplasty. The Optimotion Porous Metal-Backed Patella will come in two variations Onset styles. It is a sterile, single use, non-modular porous metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in a symmetric design that is available in multiple sizes. The metal backing features an additive manufactured porous posterior surface and three additive manufactured porous pegs to provide cemented or cementless fixation to bone.
6.6 Intended Use
The Optimotion Implants Porous Metal-Backed Patella is intended for cemented or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084).
General Total Knee Arthroplasty (TKR) Indications:
- 0 Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, Post-traumatic loss of knee joint configurations and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure.
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracturemanagement techniques.
- Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use.
- . Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.
6.7 Summary of Technological Characteristics
Device comparisons and performance testing show that the Optimotion Implants Porous Metal-Backed Patella is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
6.8 Performance Testing
Optimotion Implants Porous Metal-Backed Patella utilizes the Performance testing of the Optimotion™ Blue Total Knee System (K191084) which was performed per the FDA "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA", consultations with professionals at testing centers, Optimotion™ Implants' surgeon advisors, and engineering consultants as follows. Optimotion Implants Porous Metal-Backed Patella utilizes the same additive manufacture and processes as the currently cleared Optimotion™ Blue Total Knee System (K191084). The completed testing can be found in Appendix E-1. The following is what was tested.
- Additive Titanium Porous Structure
- O Percent Porosity and Average Pore Size
- Shear Static and Fatigue O
5
Premarket Notification:
Optimotion Implants Porous Metal-Backed Patella
6.9 Conclusions
The subject device has similiar design features, materials, and indications for use as the predicate devices. The testing performed for the predicate device indicates that the Optimotion Implants Porous Metal-Backed Patella is safe for clinical use.
The Optimotion Implants Porous Metal Backed Patella is substantially equivalent to the predicate device.