(70 days)
Joint replacement is indicated for patients suffering from disability due to:
• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.
Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.
This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows:
A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component.
A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration.
The provided text is a 510(k) premarket notification for knee joint components (EXPRT Knee Femoral Augment and EXPRT Revision Knee Stem Extension). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than comprehensive de novo clinical studies with acceptance criteria or ground truth establishment as might be seen for novel AI/ML medical devices.
Therefore, many of the requested categories are not applicable to this document. I will fill in the information that is available and indicate when a category is not applicable based on the nature of this submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Compatible with existing EXPRT Revision Knee system and demonstrably equivalent to predicate devices in function. | "Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation.""All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices." |
| Material: Use of established biocompatible materials. | Ti alloy for femoral augment, CoCrMo alloy for stem extension. These are standard materials used in knee prostheses and are implicitly considered acceptable due to their use in predicate devices. |
| Biocompatibility/Safety (Endotoxin): Meet endotoxin limits for implanted devices. | "Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits." |
| Sterilization: Compatible with established sterilization methods. | Implied to be consistent with the predicate device and standard for such implants, as "sterilization" is listed as a comparable feature to predicate devices. |
| Indications for Use: Indications should align with the predicate device, demonstrating similar clinical application. | The indications for use provided are standard for knee joint replacement due to conditions like arthritis, avascular necrosis, post-traumatic issues, and deformities, aligning with established uses for such devices. |
| Design: The device design (e.g., thickness, length, fixation method) should function as intended and be comparable or justified in differences to predicate designs. | Femoral augment: 5mm thick, 4 sizes, covers posterior or distal femoral resection, fits cement pocket.Stem extension: 40mm long, straight, fluted, cemented application, for tibial base plate and femoral component. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Applicable. This submission relies on substantial equivalence through non-clinical testing (drawing review, tolerance stack-ups, anatomic bone model evaluation) rather than a statistical test set of clinical cases.
- Data Provenance: Not Applicable. No human data (clinical or image-based) test set was used. The "anatomic bone model evaluation" likely refers to in-vitro testing or simulations rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission. Design and engineering expertise would have been implicitly involved in the "drawing review with tolerance stack ups" and "anatomic bone model evaluation."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is not an AI/ML diagnostic or assistive tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The concept of "ground truth" in the context of a diagnostic or predictive device does not apply to this physical implant. Equivalence was demonstrated through engineering analyses and material testing against established standards and predicate device characteristics.
8. The sample size for the training set
- Not Applicable. This device is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth was established for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2016
Encore Medical, L.P. % Teffany Hutto Manager. Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K161945
Trade/Device Name: EXPRT Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension(40mm) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 22, 2016 Received: August 24, 2016
Dear Ms. Hutto:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known) | K161945 |
| Device Name | EXPRT Revision Knee Femoral Augment (5mm) EXPRT Revision Knee Stem Extension (40mm) |
| Indications for Use (Describe) | Joint replacement is indicated for patients suffering from disability due to:• degenerative, post-traumatic or rheumatoid arthritis;• avascular necrosis of the femoral condyle;• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;• moderate valgus, varus or flexion deformities;• treatment of fractures that are unmanageable using other techniques.This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.Exprt Revision Knee Femoral Augments are also to be attached to the femoral component 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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FORM FDA 3881 (8/14) Page 1 of 1
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510(k) Summary
Date: September 23, 2016
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Exprt Revision Knee Femoral Augment (5mm)Exprt Revision Knee Stem Extension (40mm) | Class II | JWH | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesis per 21 CFR 888.3560 |
Description:
This Special 510(k) is to add additional components to the currently cleared Exprt Revision Knee. These components are as described as follows:
A 5mm thick, machined, Ti alloy, distal femoral augment which will be available in 4 sizes. The augment covers either the posterior femoral resection in a horizontal orientation or the distal femoral resection in a vertical orientation and fits within the cement pocket of the femoral component.
A shorter cemented stem extension for use with both the tibial base plate and the femoral component. The stem, made from CoCrMo alloy, is fluted along its length for rotational constraint when cemented. The stem is available in a 40mm long, straight configuration.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities; .
- . treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.
Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.
Predicate Devices: DJO Surgical Foundation Knee Augment Blocks - K941306 DJO Surgical Exprt Revision Knee - K140830
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Comparable Features to Predicate Device(s):
These components are comparable to the predicate devices in indications, material, design features, surgical implantation technique, intended use, packaging, and sterilization.
Key Differences in Subject Device to Predicate: Femoral stem augments: Different method of fixation to predicate. Stem extension: Shorter length than predicate.
Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.
Non-Clinical Testing: Analyses were performed which included drawing review with tolerance stack ups and anatomic bone model evaluation. All evaluations have determined that the devices are substantially equivalent to the applicable predicate devices.
Clinical Testing: Clinical testing was not required.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.