VLP MINI-MOD 2.0mm Column Plates

K163086 · Smith & Nephew, Inc. · HRS · Dec 21, 2016 · Orthopedic

Device Facts

• Record ID: K163086
• Device Name: VLP MINI-MOD 2.0mm Column Plates
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Device Story

VLP MINI-MOD 2.0mm Column Plates are metallic bone fixation implants; line addition to existing VLP MINI-MOD Small Bone Plating System. Used for fracture fixation, arthrodesis, reconstruction, and reduction of small bones/fragments; provides non-load bearing stabilization for long bone fragments. Operated by orthopedic surgeons in clinical/surgical settings. Plates are used with previously cleared 2.0mm locking and cortex screws. Device provides mechanical stabilization of bone segments to facilitate healing. Benefit includes restoration of skeletal alignment and stability in small bone fractures or reconstructive procedures.

Clinical Evidence

Bench testing only. Evidence includes finite element analysis (FEA) to assess structural integrity and engineering rationale comparing fatigue performance to the predicate (K132886). Bacterial endotoxin testing performed per ANSI/AAMI ST72 standards.

Technological Characteristics

Metallic bone plates; line addition to existing system. Utilizes 2.0mm locking and cortex screws. Mechanical performance validated via FEA and four-point bend fatigue testing. Sterility maintained per FDA guidance and ANSI/AAMI ST72. No software or electronic components.

Indications for Use

Indicated for adolescent (12-18 yrs), transitional adolescent (18-21 yrs), and adult patients, including those with osteopenic bone, requiring fracture fixation, arthrodesis, reconstruction, replantation, or reduction of small bones/fragments, and non-load bearing stabilization of long bone fragments.

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 Variable-Angle Locking Mini-Fragment Plating System (K132886)
• Smith & Nephew Bone Plate System (K993106)

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

December 21, 2016

Smith & Nephew, Inc. Samantha Staubach Regulatory Affairs Specialist 1450 Brooks Rd Memphis. Tennessee 38116

Re: K163086

Trade/Device Name: VLP MINI-MOD 2.0 mm Column Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS Dated: November 2, 2016 Received: November 3, 2016

Dear Ms. 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 [phone] or [phone] 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 [phone] or [phone] 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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# Indications for Use

510(k) Number (if known) K163086

Device Name VLP MINI-MOD 2.0mm Column Plates

#### Indications for Use (Describe)

The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone.

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

| 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: | December 21, 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 MINI-MOD 2.0mm Column Plates |
| Common Name: | Bone plates |
| Device Classification Name and<br>Reference: | 21CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HRS |

#### Predicates

Table 5-1: Substantially equivalent predicates

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|----------------------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Smith & Nephew Variable-Angle<br>Locking Mini-Fragment Plating<br>System (Primary Predicate) | K132886 | 2/4/2014 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate<br>System | K993106 | 12/9/1999 |

#### Device Description

The subject VLP MINI-MOD 2.0mm Column Plates are line addition plates to the VLP MINI-MOD Small Bone Plating System. The VLP MINI-MOD Small Bone Plating System was initially cleared for market via K132886 as the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. The proposed plates are intended to be used with the 2.0mm Locking and Cortex screws previously cleared via K132886.

#### Indications for Use

The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This

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system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

# Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed VLP MINI-MOD 2.0mm Column Plate is substantially equivalent to the legally marketed predicate devices described in Table 5-1 with regard to intended use, indications for use, and performance characteristics.

# Summary of Pre-Clinical Testing

- Finite element analysis (FEA) was conducted on the proposed VLP MINI-MOD 2.0mm . Column Plate to determine if it represented a new worst case compared against the existing MINI-MOD plates cleared via K132886. The subject plate did not represent a new worst case plate design.
- An engineering rationale was used to leverage the four-point bend fatigue testing that was previously conducted on the worst-case plate of the VLP MINI-MOD product family cleared via K132886. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate when tested at the same bending moment. Due to the fact that the subject plate did not represent a new worst case, the testing was also applicable to the subject line addition plate.
- . 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.

### Conclusion

This Traditional 510(k) premarket notification is being submitted to required clearance for the line addition VLP MINI-MOD 2.0mm Column Plate. Based on similarities to the predicate component and a review of the engineering rationale/mechanical testing previously conducted, the devices are substantially equivalent to the predicates described in Table 5-1.