(349 days)
No
The 510(k) summary describes a total knee replacement system made of standard materials and tested using standard pre-clinical methods. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, the Optimotion™ Blue Total Knee System, is a total knee replacement system intended for replacing articular surfaces of the knee to address painful and disabling joint diseases. This aligns with the definition of a therapeutic device which aims to treat or alleviate a medical condition.
No
The device is a total knee replacement system, which is a prosthetic implant for surgical treatment of knee conditions, not for diagnosing them.
No
The device description explicitly details physical components made of various alloys and UHMWPE, indicating it is a hardware medical device (a total knee system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Optimotion™ Blue Total Knee System is a surgical implant designed to replace the articular surfaces of the knee joint. It is composed of physical components (femoral, tibial, patella, etc.) made of various materials.
- Intended Use: The intended use is to treat painful and disabling joint diseases of the knee through surgical replacement.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, the Optimotion™ Blue Total Knee System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Painful, disabling joint disease of the 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 fracture-management techniques.
Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
OIY, JWH, MBH
Device Description
Optimotion™ Blue Total Knee System consists of femoral, tibial tray, tibial insert, and patella resurfacing components, tibial stem extensions and a tibial trays are composed of Ti-6Al-4V alloy, both non-porous (uncoated - cemented) or porous (cemented or cementless). All tibial insert and patella components are composed of UHMWPE with Vitamin E. The tibial stem extensions and plug are composed of Ti-6AI-4V alloy. The femoral components are composed of CoCrMo alloy either uncoated (non-porous - cemented), and coated with porous CoCrMo sintered porous coating. The non-porous cemented tibial tray and femur are only to be used with PMMA bone cement. The porous tibial tray can either be used with cement or cementless. The porous CoCr femur is compatible with both cemented and cementless applications. The Optimotion™ Blue Total Knee System is intended for cemented or uncemented replacement of the tibia, patella and femur articular surfaces of the knee.
Femoral Components: Femoral components are designed in right and left configurations and are available in cruciate retaining (CR) designs.
Tibial Insert: The tibial inserts are available in cruciate retaining asymmetric design (CR) and highly congruent (HCCR) design. Both Tibial Inserts options are available in a range of thicknesses.
Tibial Tray Components: Symmetric Tibial Trays Components are compatible with both types of Tibial Inserts.
Patellar Components: Patellar resurfacing components are available in only cemented symmetric options. Use of patellar component is optional.
Modular Stem Extensions: Modular stem extensions are available in a variety of stem lengths and diameters for use in cemented and non-cemented applications. Modular stem extensions are not intended for use when there is insufficient bone stock available for implantation.
Tibial Plug: The Tibial Plug is available in one universal size and mates with both Cemented and Porous Tibial Tray Components. The use of the Tibial Plug is optional.
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)
Pre-clinical performance testing was performed for Optimotion™ Blue Total Knee System per the FDA Guidance Document "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA", ASTM and ISO consensus standards, and publicly available information. The performance data presented in this 510(k) notification show Optimotion™ Blue Total Knee System to meet the standards for total knee replacement devices and to be substantially equivalent to the predicate device.
- Tibial baseplate fatigue strength per ASTM F1800. Tibial stem fatigue and . fretting corrosion assessment.
- Range of Motion (ROM), contact pressure, and area of tibiofemoral articulation of UHMWPE ● inserts per ASTM F2083. Constraint testing / analysis per ASTM F1223.
- Resistance to dislodgement of the tibial insert per ASTM F1814. ●
- Assessment of wear of the 100 kGy cross-linked, vitamin E stabilized UHMWPE tibial inserts . per ISO 14243-(1)-2002.
- Evaluation of the porous fixation surfaces for strength and morphology per the FDA quidance . document "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement", and relevant ASTM standards.
- Validation of additive manufacturing process for the tibial baseplate.
- Validation studies of packaging and shelf life. ●
- . Bacterial Endotoxin Test (BET) per ANSI/AAMI demonstrating the subject device to meet the limit of ≤ 20 EUs per device.
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.
0
April 7, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
Optimotion Implants, LLC % Robert Poggie President BioVera. Inc. 65 Promenade Saint Louis Notre Dame de Lile Perrot, J7V 7P2 CA
Re: K191084
Trade/Device Name: The Optimotion Blue Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: OIY, JWH, MBH Dated: March 31, 2020 Received: April 6, 2020
Dear Robert Poggie:
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
1
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 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 (QS) 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 medical devices and radiation-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. 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) K191084
Device Name
The Optimotion Blue Total Knee System
Indications for Use (Describe)
· Painful, disabling joint disease of the 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 fracture-management techniques.
Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate 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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510(k) SUMMARY for the Optimotion™ Blue Total Knee System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of Optimotion™ Blue Total Knee System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, |
| Province of Quebec, J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | November 6, 2019 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Optimotion Implants, LLC |
|---|---|
| Manufacturer Address: | 3505 Lake Lynda Drive, Bldg 300, Suite #206 |
| Orlando, Florida 32817 | |
| Registration Number: | Not registered at this time |
| Contact Name: | Dan Justin |
| Title: | CEO |
| Device Trade Name: | Optimotion™ Blue Total Knee System |
| Device Common Name: | Total Knee |
| Classification Name: | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, |
| Polymer/Metal/Polymer (CFR 888.3560) | |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, | |
| Porous, Coated, Polymer/Metal/Polymer | |
| (CFR 888.3565) | |
| Classification Code: | OIY, JWH, and MBH |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR sections 888.3560 and 888.3565 |
C1. PREDICATE DEVICES
| K160515 | Consensus Orthopedics PS2 Knee System |
|---|---|
| K123486 | Stryker Triathion® Tritanium Tibial Baseplates |
| K051380 | Stryker Triathlon Total Knee System |
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C2. REFERENCE DEVICES
| K1133369 | Zimmer Persona Personalized Knee System |
|---|---|
| K102927 | Consensus Orthopedics Knee System |
| K131864 | United Orthopedics CMA U2 Tibial Baseplate |
D. DEVICE DESCRIPTION
Optimotion™ Blue Total Knee System consists of femoral, tibial tray, tibial insert, and patella resurfacing components, tibial stem extensions and a tibial trays are composed of Ti-6Al-4V alloy, both non-porous (uncoated - cemented) or porous (cemented or cementless). All tibial insert and patella components are composed of UHMWPE with Vitamin E. The tibial stem extensions and plug are composed of Ti-6AI-4V alloy. The femoral components are composed of CoCrMo alloy either uncoated (non-porous - cemented), and coated with porous CoCrMo sintered porous coating. The non-porous cemented tibial tray and femur are only to be used with PMMA bone cement. The porous tibial tray can either be used with cement or cementless. The porous CoCr femur is compatible with both cemented and cementless applications. The Optimotion™ Blue Total Knee System is intended for cemented or uncemented replacement of the tibia, patella and femur articular surfaces of the knee.
Femoral Components: Femoral components are designed in right and left configurations and are available in cruciate retaining (CR) designs.
Tibial Insert: The tibial inserts are available in cruciate retaining asymmetric design (CR) and highly congruent (HCCR) design. Both Tibial Inserts options are available in a range of thicknesses.
Tibial Tray Components: Symmetric Tibial Trays Components are compatible with both types of Tibial Inserts.
Patellar Components: Patellar resurfacing components are available in only cemented symmetric options. Use of patellar component is optional.
Modular Stem Extensions: Modular stem extensions are available in a variety of stem lengths and diameters for use in cemented and non-cemented applications. Modular stem extensions are not intended for use when there is insufficient bone stock available for implantation.
Tibial Plug: The Tibial Plug is available in one universal size and mates with both Cemented and Porous Tibial Tray Components. The use of the Tibial Plug is optional.
E. INDICATIONS FOR USE
- 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 ● fracture-management techniques.
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Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cemented or Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated for cemented use only.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Optimotion™ Blue Total Knee System is a total knee system comprised of prosthetic implants and reusable instruments. The implant geometry is optimized for total articular surface replacement of the femorotibial joint. The tibial tray consists of eight (8) sizes, the tibial insert is offered in seven (7) thicknesses, the femoral component is available in eight (8) sizes, and the patella implant is available in six (6) different sizes. The porous femoral and tibial components have porous surfaces for cemented and/or cementless fixation. The tibial baseplate possesses a locking mechanism to retain the tibial insert. The tibial-femoral articulation is semi-constrained.
G. PERFORMANCE DATA
Pre-clinical performance testing was performed for Optimotion™ Blue Total Knee System per the FDA Guidance Document "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA", ASTM and ISO consensus standards, and publicly available information. The performance data presented in this 510(k) notification show Optimotion™ Blue Total Knee System to meet the standards for total knee replacement devices and to be substantially equivalent to the predicate device.
- Tibial baseplate fatigue strength per ASTM F1800. Tibial stem fatigue and . fretting corrosion assessment.
- Range of Motion (ROM), contact pressure, and area of tibiofemoral articulation of UHMWPE ● inserts per ASTM F2083. Constraint testing / analysis per ASTM F1223.
- Resistance to dislodgement of the tibial insert per ASTM F1814. ●
- Assessment of wear of the 100 kGy cross-linked, vitamin E stabilized UHMWPE tibial inserts . per ISO 14243-(1)-2002.
- Evaluation of the porous fixation surfaces for strength and morphology per the FDA quidance . document "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement", and relevant ASTM standards.
- Validation of additive manufacturing process for the tibial baseplate.
- Validation studies of packaging and shelf life. ●
- . Bacterial Endotoxin Test (BET) per ANSI/AAMI demonstrating the subject device to meet the limit of ≤ 20 EUs per device.
H. CONCLUSION
Optimotion™ Blue Total Knee System is substantially equivalent to the identified predicate devices based on the indications for use, materials, design, size, and performance data presented in this 510(k) notification.