Biomet Microfixation SternaLock 360 Sternal Closure System

K163007 · Biomet Microfixation · HRS · Nov 23, 2016 · Orthopedic

Device Facts

• Record ID: K163007
• Device Name: Biomet Microfixation SternaLock 360 Sternal Closure System
• Applicant: Biomet Microfixation
• Product Code: HRS · Orthopedic
• Decision Date: Nov 23, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

Device Story

Sternal closure system combining rigid fixation and cerclage technologies; approximates sternal halves; provides bone compression; rigidly fixates bone. Implantable components: metallic plate pre-assembled to polymer-coated metallic band; locking screws. Used in surgical settings by surgeons for sternal stabilization. Cerclage distributes forces around sternal bone; reduces fixation loss due to bone cut-through. Plate rigidly fixated to bone via locking screws. Benefits patient by promoting fusion and maintaining sternal stability.

Clinical Evidence

No clinical data was necessary for the determination of substantial equivalence. Bench testing was not required as the device is identical to the predicate.

Technological Characteristics

Comprised of Commercially Pure Titanium plates and bands, Parylene-C coated bands, and Titanium Alloy (Ti-6Al-4V) locking screws/mechanisms. Non-implantable stainless steel needles included. Steam/Ethylene Oxide sterilization. Single-use implants.

Indications for Use

Indicated for stabilization and fixation of sternal fractures, including post-sternotomy and sternal reconstructive procedures, to promote fusion. Suitable for patients with normal or poor bone quality. Contraindicated in patients with active infection, foreign body sensitivity, or mental/neurologic conditions preventing adherence to postoperative care.

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

• Biomet Microfixation SternaLock® 360 Sternal Closure System (K151019)

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 23, 2016

Biomet Microfixation Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K163007

Trade/Device Name: Biomet Microfixation Sternalock® 360 Sternal Closure 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 Dated: October 25, 2016 Received: October 28, 2016

Dear Ms. Jasper:

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,

# 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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# Indications for Use

510(k) Number (if known): K163007

Device Name: Biomet Microfixation SternaLock® 360 Sternal Closure System

Indications for Use: The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

Prescription Use xx (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, black letters. Below that, in smaller gray letters, is the word "MICROFIXATION". There is a thin green line separating the two words.

#### One Surgeon. One Patient.

## 510(k) Summary

Prepared November 22, 2016

| Submitter: | Biomet Microfixation<br>1520 Tradeport Drive<br>Jacksonville, FL 32218 |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialist<br>[e-mail]<br>Telephone: [phone]<br>Fax: [phone] |

Device Name: Biomet Microfixation SternaLock® 360 Sternal Closure System

Common or Usual Name: Bone Plate

Classification Name: Plate, Fixation, Bone

#### Device Classification:

| Product Code | Classification<br>Name | Device<br>Classification | Regulation<br>Number | Regulation Description |
|--------------|--------------------------|--------------------------|----------------------|-----------------------------------------------------------------------------------|
| HRS | Plate, Fixation,<br>Bone | 2 | 888.3030 | Single/multiple component<br>metallic bone fixation<br>appliances and accessories |

Indications for Use: The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

Contraindications: 1. Active infection. 2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Device Description: The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.

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### Predicate Devices:

K151019, Biomet Microfixation SternaLock® 360 Sternal Closure System

The similarities of the subject devices to the predicate devices are as follows:

- . The indications for use and contraindications are identical to that of the predicate device.
- The design of the subject devices is equivalent to the predicate devices.
- The sterilization method (steam sterilization) of the subject devices is equivalent to the predicate ● devices.
- The materials of the subject devices are equivalent to the predicate devices.

The changes proposed by this Special 510K are to update various sections of the Package Insert to provide additional information to users.

Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence.

Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Sterilization Information: The implants are provided sterile by the manufacturer; sterilization method is exposure to Ethylene Oxide gas. Implants are single use and cannot be re-sterilized by the user. The reusable instrumentation (identified by outer product label) is provided non-sterile to be sterilized by the end user.

Bacterial endotoxin testing was completed and met the defined endotoxin limit defined in FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."

Substantial Equivalence: The proposed devices have indications for use as the predicate devices. The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates. It is concluded that the information included in this summary supports substantial equivalence.