Biomet Microfixation RibFix Blu Thoracic Fixation System

K151173 · Biomet Microfixation · HWC · May 26, 2015 · Orthopedic

Device Facts

• Record ID: K151173
• Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System
• Applicant: Biomet Microfixation
• Product Code: HWC · Orthopedic
• Decision Date: May 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

Device Story

The RibFix Blu Thoracic Fixation System consists of metallic locking screws designed for use with previously cleared metallic locking bone plates to provide rigid fixation of chest wall and sternal fractures or osteotomies. The system is used by surgeons in a clinical/surgical setting. The screws are available in 2.4mm and 2.7mm diameters with self-drilling or self-tapping tip designs and lengths ranging from 7mm to 16mm. The device is provided non-sterile and requires user sterilization prior to implantation. By providing rigid fixation, the system promotes bone union in both normal and poor bone conditions, aiding in the stabilization of the chest wall following trauma or surgery.

Clinical Evidence

No clinical data was necessary for the determination of substantial equivalence. Bench testing was not required.

Technological Characteristics

Metallic locking screws manufactured from Titanium Alloy (Ti-6Al-4V). Diameters: 2.4mm and 2.7mm. Tip designs: self-drilling and self-tapping. Lengths: 7mm to 16mm. System is non-sterile, intended for user sterilization. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients requiring stabilization and fixation of chest wall fractures, including sternal reconstructive procedures, trauma, or planned osteotomies. Suitable for use in normal and poor bone. Contraindicated for patients spanning a midline sternotomy, those with active infection, foreign body sensitivity, or mental/neurologic conditions preventing adherence to postoperative care.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Biomet Microfixation Thoracic Fixation System (K142823)

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 26, 2015

Biomet Microfixation Ms. Lauren Jasper Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K151173

Trade/Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 30, 2015 Received: May 1, 2015

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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

K151173 510(k) Number (if known):

Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation System

Indications for Use: The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

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, dark gray letters. Below that, the word "MICROFIXATION" is in smaller, lighter gray letters. Underneath the words is a thin, light green line, and below that are the words "One Surgeon. One Patient." in a light gray font.

## 510(k) Summary

Prepared April 30, 2015

| 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 RibFix Blu Thoracic Fixation System

Common or Usual Name: Bone Screw

Classification Name: Screw, Fixation, Bone

#### Device Classification:

| Product Code | Classification<br>Name | Device<br>Classification | Regulation<br>Number | Regulation Description |
|--------------|--------------------------|--------------------------|----------------------|-------------------------------------------------------|
| HWC | Screw,<br>Fixation, Bone | 2 | 888.3040 | Smooth or threaded metallic<br>bone fixation fastener |

Indications for Use: The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

Contraindications: 1. Spanning a midline sternotomy; 2. Active infection; 3. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation: 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Device Description: The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking screws that are utilized with previously cleared metallic locking bone plates. These devices provide rigid fixation of fractures and osteotomies of the chest wall and sternum. The locking screws are offered in two diameters, 2.4mm and 2.7mm. The 2.4mm diameter screws are offered with two tip designs, self-drilling and self-tapping, and range in lengths from 7mm to 16mm. The 2.7mm diameter screws are offered with a self-tapping tip design and range in lengths from 7mm to 16mm. The locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).

#### Predicate Devices:

K142823, Biomet Microfixation Thoracic Fixation System

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#### The similarities of the new thoracic fixation device to the predicate device are as follows:

- o The indications for use are identical to that of the predicate device.
- o Both systems leverage rigid fixation technology through the use of locking plates and locking screws.
- Locking plates and screws are manufactured out of the same materials as the predicate devices. ●
- Locking screw self-drilling tip geometry is identical to predicate screw design. There are no ● changes to material, thread design, or manufacturing processes from the predicate devices.
- o There are no changes to sterilization methods; subject and predicate devices are sold non-sterile and are intended to be sterilized by the user prior to implantation.

#### The changes proposed by this new thoracic fixation device are as follows:

- The addition of a self-tapping screw in the 2.4mm diameter (the predicate device only features a ● self-drilling tip in the 2.4mm diameter). The predicate device utilizes a self-tapping screw design only in the 2.7mm diameter.
- The addition of the shorter 7mm length screw. Predicate device featured a shortest length of 8mm. As a result the IFU will be updated to reference this additional screw length.
- Screw lengths from 8mm to 16mm of both the self-drilling 2.4mm and self-tapping 2.7mm diameter are identical to predicate screws, except they have been given a new part number to coordinate with their system.

| | Subject Device | Predicate Device |
|----------------|-----------------------------------------------------|-------------------------------------|
| Minimum Length | 7mm | 8mm |
| Maximum Length | 16mm | 20mm |
| Diameter | 2.4mm and 2.7mm | 2.4mm and 2.7mm |
| Tip Design | Primary (2.4mm): Self-<br>Drilling and Self-Tapping | Primary (2.4mm): Self-<br>Drilling |
| | Emergency (2.7mm): Self-<br>Tapping | Emergency (2.7mm): Self-<br>Tapping |

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 non-sterily to be sterilized by the end user.

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.