BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

K111908 · Biomet Microfixation, Inc. · HWC · Nov 29, 2011 · Orthopedic

Device Facts

• Record ID: K111908
• Device Name: BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
• Applicant: Biomet Microfixation, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

Device Story

System comprises titanium plates and 2.4mm/2.7mm self-drilling screws (max 20mm length); used for sternal fixation/stabilization following sternotomy or reconstructive surgery. Surgeon applies plates and screws to sternum to promote bone fusion; self-drilling design eliminates need for pre-drilling. Device provides mechanical stability for patients with normal or osteoporotic bone. Used in surgical settings; output is physical stabilization of bone segments. Benefits include improved fatigue resistance and shear force performance compared to traditional stainless steel wire, potentially reducing nonunion or migration risks.

Clinical Evidence

Bench testing only. Mechanical testing compared the Sternalock Blu Plating System to stainless steel surgical wire using polyurethane foam substrates as mechanical models for osteoporotic human cancellous bone. Results showed the plating system had better performance in fatigue testing, shear force testing, and lateral pull-apart testing.

Technological Characteristics

Materials: Titanium plates and screws. Dimensions: 2.4mm and 2.7mm diameter screws, lengths up to 20mm. Principle: Mechanical bone fixation via plates and self-drilling screws. Sterilization: Non-sterile, single-use; validated steam sterilization required.

Indications for Use

Indicated for stabilization and fixation of anterior chest wall fractures, including post-sternotomy and sternal reconstructive procedures, to promote fusion. Suitable for patients with normal or poor bone quality.

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

• Lorenz Sternal Closure System with Modular Screw (K011076)
• Lorenz Sternal Closure System (K033740)
• Lorenz Sternal Closure System (K063506)
• Biomet Microfixation Sternal Closure System (K110574)
• Synthes Sternal Closure System (K093772)
• Synthes Zipfix (K110789)
• Ethicon Stainless Steel Suture Wire (K931271)
• Ethicon Stainless Steel Suture Wire (K946173)

Submission Summary (Full Text)

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NOV 2 9 2011

# 510(k) Summarv

September 27, 2011

Contact: Biomet Microfixation 1520 Tradeport Drive : Jacksonville, FL 32218-2480

Kim Reed, Regulatory Affairs Manager [e-mail] 904-741-9443 fax [phone]

Device Name: Biomet Microfixation Sternal Closure System Common Name: Plates and Screws

Classification Name: Single/multiple component metallic bone fixation appliances and accessories

Device Product Code: 87HRS (21 CFR 888.3030) Device Classification: Class II

Intended Use: The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

Description: Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

### Material: Titanium

Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.

### Possible risks:

- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or 1. infection can cause loosening, bending, cracking or fracture of the device.
- Nonunion or delayed union, which may lead to breakage of the implant. 2.
- 3. Migration, bending, fracture or loosening of the implant.
- 4. Metal sensitivity, or allergic reaction to a foreign body.
- 5. Decrease in bone density due to stress shielding.
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Increased fibrous tissue response around the fracture site and/or the implant. 7.
- 8. Necrosis of bone.
- Inadequate healing. g.
- 10. Selection of screws which are longer than the depth of the sternum may cause possible impingement on structures internal to the chest wall including vessels, pleura and other structures.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.

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Image /page/1/Picture/1 description: The image shows the logo for Biomet Microfixation. The logo consists of the word "BIOMET" in a stylized font, with the word "MICROFIXATION" underneath in a smaller, sans-serif font. The logo is black and white and appears to be a vector graphic.

Substantial Equivalence: Biomet Microfixation considers the Biomet Microfixation Sternal Closure System to be equivalent to the Lorenz Sternal Closure System with Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biomet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K110789), and Ethicon K931271 and K946173 Stainless Steel Suture Wire.

| Characteristic | Device In this submission | Predicates:<br>K011076,<br>K033740,<br>K063506,<br>K110574 | Predicates: Synthes K093772<br>and K110789 | Ethicon Stainless steel suture<br>wire K931271 and K946173 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The Sternal Closure System<br>includes the same plate and screw<br>configurations contained in the predicate<br>510k's listed to the right. | Identical | K093772 Titanium plates and<br>screws plates and screws<br>K110789 (PEEK Optima LT-3)<br>cable ties with detachable,<br>stainless steel needle. | Stainless steel wire |
| Material | Plates: Titanium<br>Screws: Titanium | Plates: Titanium<br>Screws: Titanium | Plates: Titanium<br>Screws: Titanium<br>Zipfix: PEEK LT-3 | 316L Stainless steel |
| Size Range | Plates: various configurations<br>Screws: 8mm to 20mm length | Plates: various<br>configurations<br>Screws:<br>8mm to 20mm length | unknown | Unknown |
| Indication | The Biomet Microfixation<br>Sternal Closure System is<br>intended for use in the<br>stabilization and fixation of<br>fractures of the anterior chest<br>wall including sternal fixation<br>following sternotomy and<br>sternal reconstructive surgical<br>procedures, to promote<br>fusion. The Biomet<br>Microfixation Sternal Closure<br>System is intended for use in<br>patients with normal and poor<br>bone quality. | The Biomet Microfixation<br>Sternal Closure System is<br>intended for use in the<br>stabilization and fixation of<br>fractures of the anterior chest<br>wall including sternal fixation<br>following sternotomy and<br>sternal reconstructive surgical<br>procedures. | Intended for use in the<br>primary or secondary<br>closure/repair of the sternum<br>following sternotomy or<br>fracture of the sternum to<br>stabilize the sternum and<br>promote fusion. | Current standard of care for<br>sternal closure applications – all<br>bone types<br><br>A nonabsorbable, sterile surgical<br>suture composed of 316L<br>stainless steel. Surgical stainless<br>steel suture is available as a<br>monofilament. Indicated for use<br>in abdominal wound closure,<br>hernia repair, sternal closure and<br>orthopaedic procedures including<br>cerclage and tendon repair. |
| Non-Clinical Testing | | | | |
| Mechanical testing was performed to compare the Sternalock Blu Plating System to Stainless Steel surgical wire, for sternal closure. The testing was<br>conducted using a polyurethane foam substrate which simulates Osteoporotic bone (see Patel Article, "Compressive properties of commercially<br>available polyurethane foams as mechanical models for osteoporotic human cancellous bone") The mechanical testing showed that the Sternalock<br>Blu Plating System had better performance compared to stainless steel surgical wire with respect to fatigue testing, shear force testing and lateral | | | | |

: .

. .

pull apart testing.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomet Microfixation % Ms. Kim Reed Regulatory Affairs Manager 1520 Tradeport Drive Jacksonville, Florida 32218

NOV 2 9 2011

Re: K111908

Trade/Device Name: Biomet Microfixation Sternal Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: September 27, 2011 Received: October 3, 2011

Dear Ms. Reed:

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

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# Page 2 - Ms. Kim Reed

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K111908

Device Name: Biomet Microfixation Sternal Closure System

Indications For Use:

The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and 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 GDRH, Office of Device Evaluation (ODE)

Mitchel Dues for MXM
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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**510(k) Number** 111508