(269 days)
No
The summary describes a mechanical knee implant system and its materials, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device, the Engage™ Partial Knee System, is intended for medial unicompartmental knee arthroplasty to treat conditions like painful osteo- or post-traumatic arthritis. This directly addresses medical conditions to restore function and alleviate pain, classifying it as a therapeutic device.
No
The Engage™ Partial Knee System is a surgical implant designed for knee replacement, not for diagnosing medical conditions. Its intended use is to treat osteoarthritis and post-traumatic arthritis by replacing parts of the knee joint.
No
The device description clearly states it is comprised of physical components like tibial trays, tibial inserts, tibial anchors, and femoral components made of various alloys and UHMWPE, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Engage™ Partial Knee System is a surgical implant designed to replace a portion of the knee joint. It is physically implanted into the patient's body.
- Intended Use: The intended use is to treat conditions like arthritis and revise previous surgical procedures by replacing damaged parts of the knee. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The provided text clearly describes a medical device used for surgical implantation and treatment, not for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
- As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
Product codes (comma separated list FDA assigned to the subject device)
NJD, HSX
Device Description
The Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial unicompartmental 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 the Engage™ Partial 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 for the Engage™ Partial Knee System demonstrate its substantial equivalence to the identified predicate device unicompartmental knee device.
- Tibial baseplate fatigue strength per three-point bend method as described in ASTM F3140.
- 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.
- Evaluation of the tibial baseplate and tibial anchor assembly.
- Biomechanical evaluation of the tibial tray and anchor assembly under cyclic loading.
- Evaluation of the porous fixation surfaces per the FDA guidance document "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement".
- Validation of additive manufacturing process for the tibial baseplate.
- Validation studies of packaging and shelf life testing.
- Bacterial endotoxins test (BET), also known as Limulus Amebocyte Lysate (LAL) testing.
- Validation of reusable instrument reprocessing parameters including sterilization with ONE TRAY® Sealed Container System (K052567).
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
§ 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented 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 surface. 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 baseplate.(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
November 21, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Engage Surgical Mr. Nicholas Slater Chief Operating Officer 3225 N. Colorado St Chandler, Arizona 85225
Re: K190439
Trade/Device Name: Engage™ Partial Knee System Regulation Number: 21 CFR 888.3535 Regulation Name: Knee Joint Femorotibial (Uni-Compartmental) Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: NJD, HSX Dated: October 21, 2019 Received: October 22, 2019
Dear Mr. Slater:
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,
for William Jung, Ph.D. Director (Acting) 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) K190439
Device Name The Engage™ Partial Knee System
Indications for Use (Describe)
The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
- As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
| 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 Engage™ Partial Knee System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of substantial equivalence of The Engage™ Partial Knee System.
A. SUBMITTERS INFORMATION
| Submitter Name: | Engage Surgical |
|---|---|
| Submitter Address: | 3225 N. Colorado Street, Chandler, AZ 85225 USA |
| Contact Person: | Nick Slater |
| Title: | Chief Operating Officer |
| Phone Number: | 570-713-9227 |
| Fax Number: | 407-641-8611 |
| Date of Submission: | October 21, 2019 |
B. MANUFACTURER & DEVICE IDENTIFICATION
| Manufacturer Name: | Engage Surgical |
|---|---|
| Manufacturer Address: | 3505 Lake Lynda Drive, Suite 206 |
| Orlando, Florida 32817 | |
| Device Trade Name: | The Engage™ Partial Knee System |
| Device Common Name: | Unicompartmental Knee |
| Classifications: | 21 CFR 888.3535 – Knee joint femorotibial (uni-compartmental) |
| metal/polymer porous-coated uncemented prosthesis | |
| 21 CFR 888.3520 – Knee joint femorotibial metal/polymer non- | |
| constrained cemented prosthesis | |
| Product Codes: | NJD and HSX |
| Classification Panel: | Orthopedic |
| C1. PRIMARY | |
| PREDICATE DEVICE | |
| K133811 | Mako Surgical Inc.'s Restoris Porous Partial Knee System |
| C2. ADDITIONAL | |
| PREDICATE DEVICES | |
| K033810 | |
| K163700 | Centerpulse Orthopedics, Inc.'s Natural-Knee II Unicompartmental |
| Knee System | |
| BodyCAD Unicompartmental Knee System | |
| C3. REFERENCE DEVICES | |
| K142066 | |
| K033363 | Stryker Spine AERO-LL Lumbar Cage System |
| Zimmer Unicompartmental Knee System (ZUK) |
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D. DEVICE DESCRIPTION
The Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.
E. INDICATIONS FOR USE
The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:
- · Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis.
- · Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
- · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The femoral component and tibial tray are intended for cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
F. PERFORMANCE DATA
Pre-clinical performance testing was performed for the Engage™ Partial 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 for the Engage™ Partial Knee System demonstrate its substantial equivalence to the identified predicate device unicompartmental knee device.
- Tibial baseplate fatigue strength per three-point bend method as described in ASTM F3140.
- 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.
- Evaluation of the tibial baseplate and tibial anchor assembly.
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- Biomechanical evaluation of the tibial tray and anchor assembly under cyclic loading. .
- . Evaluation of the porous fixation surfaces per the FDA guidance document "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement".
- Validation of additive manufacturing process for the tibial baseplate. ●
- . Validation studies of packaging and shelf life testing.
- Bacterial endotoxins test (BET), also known as Limulus Amebocyte Lysate (LAL) testing. .
- Validation of reusable instrument reprocessing parameters including sterilization with ONE ● TRAY® Sealed Container System (K052567).
G. SUBSTANTIAL EQUIVALENCE
The Engage™ Partial Knee System is substantially equivalent to the identified predicate device based on similarities in indications for use, materials, design, size, and performance data presented in this 510(k) notification.