Smith & Nephew VISIONAIRE Adaptive Guides
Device Facts
| Record ID | K170282 |
|---|---|
| Device Name | Smith & Nephew VISIONAIRE Adaptive Guides |
| Applicant | Smith & Nephew, Inc. |
| Product Code | JWH · Orthopedic |
| Decision Date | May 22, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
Intended Use
Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use: - Genesis II Knee System - Legion Knee System - Journey BCS Knee System - Journey II Knee System The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single use only.
Device Story
Patient-specific surgical instrumentation (cutting blocks/guides) designed from patient imaging (MRI, X-ray); used intra-operatively by surgeons to assist in positioning total knee replacement components and marking bone before cutting. Guides are manufactured based on patient anatomy to ensure alignment. Used in conjunction with Smith & Nephew knee systems (Genesis II, Legion, Journey BCS, Journey II). Benefits include improved surgical accuracy and alignment during total knee arthroplasty. Surgeon evaluates guide position using surgical alignment instruments. Single-use device.
Clinical Evidence
No clinical data was needed. Evidence consists of cadaveric testing demonstrating performance equivalent to the predicate and software verification/validation testing conducted per FDA guidance.
Technological Characteristics
Patient-specific cutting blocks/guides manufactured from patient imaging data. Features include tibia-cut-first guide and removable tabs. Software-driven design process. Single-use. No specific material standards or energy sources listed.
Indications for Use
Indicated for patients undergoing total knee replacement requiring patient-specific surgical instrumentation for component positioning and bone marking, provided anatomic landmarks are identifiable on imaging scans. Compatible with Genesis II, Legion, Journey BCS, and Journey II Knee Systems.
Regulatory Classification
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).
Predicate Devices
- Patient Matched Cutting Blocks (K130708)
Related Devices
- K082358 — SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY · Smith & Nephew, Inc. · Nov 25, 2008
- K103598 — PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES · Wrightmedicaltechnologyinc · Oct 17, 2011
- K173445 — Materialise TKA Guide System · Materialise NV · Feb 2, 2018
- K110533 — STRYKER PATIENT SPECIFIC CUTTING GUIDE · Stryker Corp. · May 19, 2011
- K110397 — TRUMATCH PERSONALIZED SOLUTIONS · DePuy Orthopaedics, Inc. · Aug 16, 2011
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
Smith & Nephew, Inc Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K170282
Trade/Device Name: Smith & Nephew VISIONAIRE Adaptive Guides Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: January 27, 2017 Received: January 30, 2017
Dear Brad 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.
# Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. 0910-0120 | |
|-----------------------------------|--|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
**Indications for Use**
| 510(k) Number (if known) | K170282 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Smith & Nephew VISIONAIRE Adaptive Guides |
| Indications for Use (Describe) | Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. |
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew,
Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single use only.
| Type of Use (Select one or both, as applicable) | <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------|-----------------------------------------------------------------------------------------|
| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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K170282
Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The words "We are" are in gray, while "smith&nephew" is in orange. To the left of the text is an orange star-like symbol.
| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | May 18, 2017 |
| Contact Person and Address: | Brad Sheals<br>Principal Regulatory Affairs Specialist<br>T 901-399-6897<br>F 901-566-7911 |
| Name of Device: | Smith & Nephew VISIONAIRE Adaptive Guides |
| Common Name: | Knee Prosthesis |
| Device Classification Name and<br>Reference: | 21 CFR 888.3560- Knee joint patellofemorotibial<br>polymer/metal/polymer non-constrained cemented<br>prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH, MBH, OOG |
# Device Description
The subject of this premarket notification is to seek FDA clearance of the Smith & Nephew VISIONAIRE Adaptive Guides and the modifications to the software components used to design and manufacture the VISIONAIRE Patient Matched Cutting Blocks. The subject guides are designed, manufactured from patient imaging data (i.e. MRI, X-Ray) and offered in various femur/tibia options and features requested by the surgeon: a tibia-cut-first guide and options for removable tabs. Also within this notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708.
#### Intended Use
Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Adaptive Guides are intended for single use only.
Page 1 of 2.
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# Technological Characteristics
Smith & Nephew conducted cadaveric testing of the subject device. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate cutting blocks.
Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended.
Based on the testing within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device.
### Substantial Equivalence Information
The Smith & Nephew VISIONAIRE Adaptive Guides are identical in function, equivalent design features, intended use, indications for use, operational principles, manufacturing processes, and materials as the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014).
### Conclusion
This premarket notification is being submitted to request clearance for the Smith & Nephew VISIONAIRE Adaptive Guides. Based on the similarities to the predicate cutting blocks, cadaveric testing, and a review of the software validation testing performed, the subject device is substantially equivalent to the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014).
