BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Device Facts
| Record ID | K121302 |
|---|---|
| Device Name | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
| Applicant | Biomet Microfixation |
| Product Code | HRS · Orthopedic |
| Decision Date | Sep 19, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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
Sternal closure system consisting of titanium plates and screws; used for stabilization/fixation of anterior chest wall fractures and post-sternotomy/reconstructive procedures. Plates feature varying geometries (X, box, straight, L) and cuttable cross-sections to facilitate emergent re-entry. Screws (2.4mm-2.7mm) are self-drilling or pre-drilled. System is non-sterile, single-use, and intended for surgical application by physicians. Device promotes bone fusion in patients with varying bone quality. Mechanical fixation provides structural support to the sternum during the healing process.
Clinical Evidence
Bench testing only. Mechanical testing, including tensile strength, shear strength, and screw pull-out, was conducted to demonstrate performance and substantial equivalence. No clinical data provided.
Technological Characteristics
Materials: Grade IV commercially pure titanium (ASTM F-67). Dimensions: Plate thickness 0.063-0.102 inches; screw diameter 2.4-2.7mm. Principle: Mechanical bone fixation via plates and screws. Sterilization: Non-sterile, steam sterilization recommended. Connectivity: None.
Indications for Use
Indicated for patients requiring stabilization and fixation of anterior chest wall fractures, including post-sternotomy and sternal reconstruction, to promote fusion. Suitable for patients with normal or poor bone quality.
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 Sternal Closure System (K011076)
- Biomet Microfixation Sternal Closure System (K110574)
- Biomet Microfixation Sternal Closure System (K111908)
Submission Summary (Full Text)
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K121302 (pg. 1 of 2)
Image /page/0/Picture/1 description: The image shows the Biomet Microfixation logo at the top. Below the logo, the text "510(k) Summary" is displayed in a bold, sans-serif font. The text is aligned to the left and appears to be the title or heading of a document or section.
April 24, 2012
Contact: Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218-2480
Sheryl Malmberg, RA Specialist 904-741-9465 fax 904-741-9425 sheryl.malmberg@biomet.com
9 2012
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)
Intended Use: 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: The Biomet Microfixation Sternal Closure System (sometimes abbreviated SL) of plates, including the SternaLock Blu system, is made up of plates of varying shapes currently including, but not limited to, X plates, box plates, straight plates, and L plates. The plates have at least one cuttable cross section, but not more than 4 of these sections when they are intended to cross a non-transverse fracture or sternotomy. There are plates without cuttable cross sections to assist in the fixation of transverse fractures. The plates accept screws with a diameter of 2.4mm and 2.7mm. Self-drilling screws have a maximum length of 20mm. The tip of the selfdrilling screw is designed so that a predrilled hole is not required, but may be used. See chart below for more detail.
## 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:
- I. Poor bone formation, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
- 2. Nonunion or delayed union, which may lead to breakage of the implant.
- 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.
- 6. Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
- 7. Increased fibrous tissue response around the fracture site and/or the implant.
- 8. Necrosis of bone.
- 9. Inadequate healing.
- 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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## 14121302
Substantial Equivalence: Biomet Microfixation considers the Biomet Microfixation Sternal Closure System to be equivalent to the Biomet Microfixation Sternal Closure System (K011076, K110574 and K111908). There are no changes to the screws.
The SternaLock (sometimes abbreviated SL) system of plates, including the SternaLock Blu system, is made up of plates of varying shapes currently including, but not limited to, X plates, box plates, straight plates, and L plates. The following design features are common to this family:
| <b>1. Material:</b><br>A. All SL plates are machined from Grade IV commercially pure titanium as governed by ASTM F-67. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>2. Thickness:</b><br>A. Min/Max – The minimum nominal thickness for plates offered is 0.063 inches thick (as in the SL Blu system) while the maximum thickness plate is 0.102 inches thick (as in the earlier SL system). |
| <b>3. Holes for Screw Fixation:</b><br>A. Screw Diameter – the plates are compatible with SL screws with a diameter of 2.4mm to 2.7mm.<br>B. Minimum Distance – between screw holes is 0.260 inches.<br>C. Plates have at least 1 but not more than 4 holes on either side of each cuttable cross-section. |
| <b>4. Cuttable cross-section:</b> Many of the SL plates are designed with at least one tie spanning the sternotomy line to facilitate emergent re-entry by cutting through the tie(s).<br>A. Cross-sectional area – this is 0.006in2 through the tie for all SL Blu system plates, and 0.005in2 for all earlier SL system plates.<br>B. Span – The shortest span of these cuttable cross-sections is 0.056 inches (part number 73-1952). The longest span of these cuttable cross-sections is 0.382 inches (part number 73-2634).<br>C. Quantity – The plates have at least 1, but not more than 4 of these ties, when they are intended to cross a sagittal fracture or sternotomy. |
| <b>5. Transverse Fracture Plates:</b> These plates do not need cuttable cross-sections because they are intended for fixation of transverse fractures which do not cross the sternotomy line.<br>A. The plates intended for fixation of transverse fractures are distinguished by the absence of cuttable ties. The plates may have from 2 to 26 holes. |
Image /page/1/Picture/4 description: The image shows a spine with surgical plates attached to it. There are three plates in total, with one plate attached to the top of the spine and two plates attached to the middle and bottom. The plates are made of metal and have screws that are used to attach them to the spine. The plates are used to stabilize the spine after surgery.
Recommended sternal g with SternaLock Blu.
The design of new plates for the SL systems must satisfy all of the above conditions, however it is not limited in configuration.
Conclusion: Mechanical testing such as tensile strength, shear strength and screw pull out have been conducted and used to demonstrate substantial equivalence in that the devices will perform within the intended use and that no new safety and efficacy issues were raised.
14-3
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 19 2012
Biomet Microfixation % Ms. Sheryl Malmberg Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re: K121302
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 Dated: August 23, 2012 Received: August 24, 2012
Dear Ms. Malmberg:
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.
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Page 2 - Ms. Sheryl Malmberg
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson 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 Form
510(k) Number (if known): K121302
Device Name: Biomet Microfixation Sternal Closure System
Indications for Use:
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 _ X (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)
Michael Owens Ex Anton Dmitriev
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
