(90 days)
The ZUK Unicompartmental Knee System is indicated for patients with:
-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-Previous tibial condyle or plateau fractures with loss of anatomy or function.
-Varus or valgus deformities.
-Revision of previous arthroplasty procedures.
-These devices are indicated for cemented use only.
-The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Indications for JOURNEY Unicompartmental Knee Replacement: Unicompartmental knee implants are 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 functional deformity:
- Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.
Indications for JOURNEY Patello-Femoral Replacement:
· Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or patellar fracture: and
· Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew patello-femoral implants are intended for implantation with bone cement.
Indications for Combined Unicompartmental and Patello-Femoral Replacement:
· Post-traumatic arthritis;
- · Degenerative arthritis: and
- · Failed osteotomies and unicompartmental replacement
These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with bone cement.
The purpose of this 510(k) is to notify the FDA of our intent to market previously cleared Smith & Nephew knee implants with previously cleared ZUK knee implants. Together with existing Smith & Nephew knee implants, these devices will be marketed under the trade name ZUK Select Knee System. The nature of this filing is to seek FDA clearance for these existing devices to be used in various combinations to create a bicompartmental knee replacement prosthesis. No new or modified knee implant components or new device specific instruments are being introduced to this filing.
This document is a 510(k) premarket notification for the ZUK Select Knee System. It states that the device comprises existing, previously cleared components from Smith & Nephew and Zimmer. The purpose of this 510(k) is to seek clearance for using these existing devices in various combinations to create a bicompartmental knee replacement prosthesis.
Based on the provided text, a formal study to prove the device meets specific acceptance criteria is not described, as the filing relies on the substantial equivalence of its components to previously cleared devices. Therefore, much of the requested information regarding study details, sample sizes, expert ground truth, etc., is not applicable or not available within this document.
However, I can extract information about the testing performed and the conclusion regarding safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
Based on the document, specific, quantitative acceptance criteria for this new combined system are not presented in a traditional performance study format. Instead, the approach is based on demonstrating substantial equivalence to predicate devices, supported by mechanical testing.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Mechanical Performance | "Additional mechanical testing, Contact Area Analysis, was conducted on the subject device(s) to support the use of the components in combination." "Based on the testing, there are no new issues related to the safety and effectiveness of the subject device(s)." |
| Clinical Performance | "Clinical data was not needed to support the safety and effectiveness of the subject device(s)." |
| Material/Design Equivalence | "The ZUK Select Knee System is identical in function, identical design features, intended use, indications for use, operational principles because the parts are the identical product components cleared in previous premarket notifications." This essentially serves as the primary "acceptance criterion" for this type of 510(k) submission. |
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 as a traditional clinical or performance study with human or biological samples was not conducted for the ZUK Select Knee System itself. The mechanical testing mentioned (Contact Area Analysis) would involve a sample of the device components, but the specific number is not provided.
- Data Provenance: Not applicable for a clinical study. The existing components are from manufacturers (Smith & Nephew, Zimmer) operating in the USA. The data referenced is from previously cleared 510(k) submissions to the FDA.
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. Ground truth typically refers to clinical diagnostic accuracy or outcome, which was not assessed in a direct clinical study for this 510(k) filing. The "ground truth" for substantial equivalence is the prior FDA clearance of the individual components and the supporting mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as a clinical test set requiring adjudication was not utilized.
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 is a knee implant system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a knee implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) specifically, the "ground truth" for asserting safety and effectiveness lies in the prior FDA clearance of the individual components and mechanical testing (Contact Area Analysis) demonstrating that combining these components introduces no new safety/effectiveness concerns.
8. The sample size for the training set
- Not applicable. No training set for a machine learning model or a clinical training cohort was mentioned.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
Smith & Nephew, Incorporated Mr. Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K160738 Trade/Device Name: ZUK Select Knee 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, OIY, KRR, NPJ Dated: March 16, 2016 Received: March 17, 2016
Dear Mr. Sheals:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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/ResourcesforYou/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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160738
Device Name ZUK Select Knee System
Indications for Use (Describe)
The ZUK Unicompartmental Knee System is indicated for patients with:
-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-Previous tibial condyle or plateau fractures with loss of anatomy or function.
-Varus or valgus deformities.
-Revision of previous arthroplasty procedures.
-These devices are indicated for cemented use only.
-The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160738
Device Name ZUK Select Knee System
Indications for Use (Describe)
Indications for JOURNEY Unicompartmental Knee Replacement:
Unicompartmental knee implants are 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 functional deformity;
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.
Indications for JOURNEY Patello-Femoral Replacement:
· Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or patellar fracture; and
· Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew patello-femoral implants are intended for implantation with bone cement.
Indications for Combined Unicompartmental and Patello-Femoral Replacement:
- · Post-traumatic arthritis;
- Degenerative arthritis; and
- · Failed osteotomies and unicompartmental replacement
These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{4}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | March 16, 2016 |
| Contact Person and Address: | Brad ShealsPrincipal Regulatory Affairs SpecialistT 901-399-6897F 901-566-7911 |
| Name of Device: | ZUK Select Knee System |
| Common Name: | Knee Prosthesis |
| Device Classification Name andReference: | 21 CFR 888.3520- Knee joint femorotibialmetal/polymer non-constrained cemented prosthesis |
| 21 CFR 888.3540- Knee joint patellofemoralpolymer/metal semi-constrained cemented prosthesis | |
| 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSX, OIY, KRR, NP.I |
Device Description
The purpose of this 510(k) is to notify the FDA of our intent to market previously cleared Smith & Nephew knee implants with previously cleared ZUK knee implants. Together with existing Smith & Nephew knee implants, these devices will be marketed under the trade name ZUK Select Knee System. The nature of this filing is to seek FDA clearance for these existing devices to be used in various combinations to create a bicompartmental knee replacement prosthesis. No new or modified knee implant components or new device specific instruments are being introduced to this filing.
{6}------------------------------------------------
Intended Use
Indications for JOURNEY Unicompartmental Knee Replacement: Unicompartmental knee implants are 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 functional deformity:
- Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.
Indications for JOURNEY Patello-Femoral Replacement:
· Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or patellar fracture: and
· Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew patello-femoral implants are intended for implantation with bone cement.
Indications for Combined Unicompartmental and Patello-Femoral Replacement:
· Post-traumatic arthritis;
- · Degenerative arthritis: and
- · Failed osteotomies and unicompartmental replacement
These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with bone cement.
The ZUK Unicompartmental Knee System is indicated for patients with:
-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-Previous tibial condyle or plateau fractures with loss of anatomy or function.
-Varus or valgus deformities.
-Revision of previous arthroplasty procedures.
-These devices are indicated for cemented use only.
-The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
{7}------------------------------------------------
Technological Characteristics
The devices that make up the ZUK Select Knee System are existing devices previously cleared by the FDA. As result, much of the testing makes reference to existing information previously provided to the agency. Additional mechanical testing, Contact Area Analysis, was conducted on the subject device(s) to support the use of the components in combination.
Based on the testing, there are no new issues related to the safety and effectiveness of the subject device(s). Clinical data was not needed to support the safety and effectiveness of the subject device(s).
Substantial Equivalence Information
The ZUK Select Knee System is identical in function, identical design features, intended use, indications for use, operational principles because the parts are the identical product components cleared in previous premarket notifications listed in Table 5-1.
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Zimmer | Zimmer UnicompartmentalKnee System Vivacit-E ArticularSurface | K122529 | 11/16/2012 |
| Smith & Nephew, Inc. | Journey Select Knee System | K093056 | 12/15/2009 |
| Smith & Nephew, Inc. | Journey Unicondylar FemoralImplant | K081351 | 07/24/2008 |
| Smith & Nephew, Inc. | Patello-Femoral Knee Implant | K051086 | 05/31/2005 |
| Zimmer | Zimmer UnicompartmentalKnee System | K033363 | 01/16/2004 |
Table 5-1: Substantially Equivalent Predicates to the ZUK Select Knee System
Conclusion
No new or modified knee implant components or device specific instruments are being introduced as a result of this filing. Because the subject device is made up of identical product components from previous premarket notifications, the subject device is substantially equivalent to the listed predicates.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.