VLP Wrist Fracture System
Device Facts
| Record ID | K161665 |
|---|---|
| Device Name | VLP Wrist Fracture System |
| Applicant | Smith & Nephew, Inc. |
| Product Code | HRS · Orthopedic |
| Decision Date | Nov 15, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.
Device Story
VLP Wrist Fracture System is a radial plating system consisting of metallic plates, screws, and locking pegs; used for surgical fixation of radius fractures, malunions, and osteotomies. System includes volar plates (3, 5, 10 hole configurations), 1.8mm locking pegs, and 3.5mm cortex/locking screws. Operated by orthopedic surgeons in clinical/OR settings. Device provides mechanical stabilization of bone segments to facilitate healing. Surgeon selects appropriate plate/screw configuration based on fracture pattern; implants are secured to bone to maintain alignment during the healing process.
Clinical Evidence
No clinical data. Evidence consists of bench testing: finite element analysis (FEA) comparing plate designs to worst-case predicate; four-point bend fatigue testing; torque-to-failure testing for 3.5mm locking screws (meeting ASTM F543 requirements); and bacterial endotoxin testing per ANSI/AAMI ST72.
Technological Characteristics
Metallic bone fixation system (plates, screws, pegs). Materials and design similar to predicates. Mechanical performance validated via FEA and torque-to-failure testing per ASTM F543. Provided sterile. No software or electronic components.
Indications for Use
Indicated for fixation of fractures, malunions, and osteotomies involving the radius in patients requiring bone fixation.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- Smith & Nephew, Inc. D-RAD SMARTPACK (K132296)
- Smith & Nephew Bone Plate System (K993106)
- Synthes 3.5mm Cortex Screws (K043185)
- PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws (K082516)
- PERI-LOC Bone Plating and Screw System (K083032)
- Biomet Trauma Modified Distal Radius Plating System (K133939)
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
November 15, 2016
Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K161665
Trade/Device Name: VLP Wrist Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 28, 2016 Received: October 31, 2016
Dear Samantha Staubach:
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
# K161665
Device Name VLP Wrist Fracture System
#### Indications for Use (Describe)
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.
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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| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | October 28, 2016 |
| Contact Person and Address: | Samantha Staubach<br>Regulatory Affairs Specialist<br>T 901-399-6132<br>F 901-566-7596 |
| Name of Device: | VLP Wrist Fracture System |
| Common Name: | Bones Plates and Screws |
| Device Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories |
| | 21 CFR 888.3040 Smooth or threaded metallic bone fixation<br>fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS/HWC |
#### Predicates
Table 1: Substantially Equivalent Predicates to the VLP Wrist Fracture System
| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|----------------------------------------------------------------------------|----------------------|--------------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. D-RAD<br>SMARTPACK (primary predicate) | K132296 | January 7, 2014 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate System | K993106 | December 9, 1999 |
| Synthes (USA) | Synthes 3.5mm Cortex Screws | K043185 | February 3, 2005 |
| Smith & Nephew, Inc. | PERI-LOC Periarticular Locked<br>Plating System Hexalobular Bone<br>Screws | K082516 | September 17, 2008 |
| Smith & Nephew, Inc. | PERI-LOC Bone Plating and Screw System | K083032 | January 7, 2009 |
| Biomet Trauma | Modified Distal Radius Plating System | K133939 | April 1, 2014 |
## Device Description
The VLP Wrist Fracture System is a radial plating system comprised of plates, screws, and device specific instrumentation. Plates, screws, and locking pegs are provided in sterile packaging. Volar plate design options are offered in 3 hole, 5 hole, and 10 hole plate configurations, with both standard and wide sizes available for all sizes except the 10 hole plate. The 10 hole plate is available in standard size only. All plate designs are available in left and right configurations. 1.8mm Locking Pegs are available in lengths ranging from 10mm to
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30 mm and 3.5mm Cortex and Locking Screws are available in lengths ranging from 10mm to 30mm. The system uses existing Smith & Nephew 2.4mm locking and cortex screws.
### Indications for Use
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.
### Technological Characteristics
The proposed radial plates are similar to the predicates described in Table 1. Device comparisons described in this premarket notification demonstrated that the proposed bone plates and bone screws are substantially equivalent to the legally marketed predicate devices listed in Table 1 with regard to intended use, indications for use, materials, and performance characteristics. The subject plates feature similarities in design to the primary predicate, with the major difference being the increased product offering. To accommodate for the size differences in the screws compared to the primary predicate, mechanical testing was conducted on the subject screw and an engineering rationale was leveraged based on similar design features to existing Smith & Nephew screw designs.
#### Summary of Pre-Clinical Testing
- · Finite element analysis (FEA) was conducted on the proposed line addition plate designs to evaluate the proposed designs against the existing worst case plate design from K132296. Results of the testing determined that the proposed line addition plates did not represent a new worst-case when compared against the existing designs.
- Existing mechanical testing for four-point bend fatigue was leveraged based on the . fact that the 4 Hole Wide Plate design previously cleared via K132296 is also being offered in the subject system with minor modifications. As described above, FEA did not result in a new worst-case plate design compared against the existing worstcase, the 4 Hole Wide Plate cleared via K132296.
- Torque-to-failure testing was conducted on the subject 3.5mm locking screws. The . screws met the acceptance criteria by achieving an ultimate torsional strength greater than the minimum value outlined in ASTM F543.
- . An engineering rationale was leveraged in lieu of pullout testing for the proposed 3.5mm screws. The dimensions critical to screw behavior during pullout testing were compared between the subject screws and an existing Smith & Nephew predicate screw and the dimensions were identical. As such, it was determined that completion of pullout testing was not necessary.
- Bacterial endotoxin testing was completed and met the acceptable endotoxin limits . as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
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# Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the VLP Wrist Fracture System. Based on the similarities to the predicate devices and a review of the mechanical testing performed and leveraged, the devices are substantially equivalent to the plating systems described in Table 1
