Sternal Closure System

K142484 · Jace Medical, LLC · HRS · Oct 31, 2014 · Orthopedic

Device Facts

• Record ID: K142484
• Device Name: Sternal Closure System
• Applicant: Jace Medical, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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 surgical procedures.

Device Story

Sternal Closure System consists of bone plates, bone screws, and interconnecting fasteners (solid or cable versions) used for sternal stabilization. Plates available in fixed one-piece or fastenable two-piece styles. System includes surgical instruments for implantation. Used by surgeons in clinical/OR settings to fixate sternum following sternotomy or reconstructive procedures. Mechanical fixation provides stability to bone segments to facilitate healing. Device components are implanted to maintain alignment of sternal halves.

Clinical Evidence

Bench testing only. Mechanical testing performed on worst-case constructs including static and dynamic lateral distraction and static longitudinal shear. Bone screws evaluated per ASTM F543. Results demonstrate performance equivalence to predicate devices.

Technological Characteristics

Implant components manufactured from titanium alloy (ASTM F136). System includes bone plates, screws, and fasteners. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring stabilization of sternal fractures, including post-sternotomy fixation and sternal reconstructive surgical procedures.

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 (K110574, K111908, K121302)
• Ethicon Stainless Steel Suture Wire (K931271, K946173)
• Sternal Talon (K051165, K070169)

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

October 31, 2014

JACE Medical LLC Mr. Justin May Director of Engineering 536 East 200 North Warsaw, Indiana 46582

Re: K142484 Trade/Device Name: 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, HWC, JDQ Dated: August 29, 2014 Received: September 4, 2014

Dear Mr. May:

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

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Page 2 - Mr. Justin May

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 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" (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 yours,

## 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K142484

Device Name Sternal Closure System

Indications for Use (Describe)

The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Date: | 29 August 2014 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | JACE Medical, LLC<br>536 East 200 North<br>Warsaw, IN 46582 USA<br>[phone] |
| Contact Person: | Justin May, Director of Engineering |
| Trade Name: | Sternal Closure System |
| Common Name: | Cable/rod, plate and screw system |
| Device Classification: | Class II |
| Regulation, Name: | 888.3010, Bone fixation cerclage<br>888.3030, Single/multiple component metallic bone fixation<br>appliances and accessories<br>888.3040, Smooth or threaded metallic bone fixation fastener |
| Device Product<br>Codes: | JDQ, HRS, HWC |
| Device Description: | The Sternal Closure System is comprised of bone screw, bone plate<br>and fastener components and instruments for implantation. The<br>plates are offered in a fixed one-piece and a fastenable two-piece<br>style. Bone screws are available in a single diameter having a range<br>of lengths. The interconnecting components come in solid and cable<br>versions and fasten the halves of the two-piece plate. |
| Intended Use: | The Sternal Closure System is intended for use in the stabilization<br>and fixation of fractures of the sternum, including sternal fixation<br>following sternotomy and sternal reconstructive surgical procedures. |
| Materials: | The Sternal Closure System implant components are manufactured<br>titanium alloy as described by ASTM F136. |
| Predicate Devices: | Biomet Microfixation Sternal Closure System (Biomet Microfixation:<br>K110574, K111908, K121302)<br>Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271,<br>K946173)<br>Sternal Talon (KLS Martin, LP: K051165, K070169) |
| Performance Data: | Mechanical testing of the worst case Sternal Closure System<br>constructs was performed in static and dynamic lateral distraction<br>and static longitudinal shear. Sternal Closure System bone screws<br>were evaluated according to ASTM F543.<br>The mechanical test results demonstrate that the Sternal Closure<br>System construct performance is substantially equivalent to the<br>Ethicon Stainless Steel Suture Wire and that the Sternal Closure<br>System screw performance is substantially equivalent to the Biomet<br>Microfixation Sternal Closure System screws. |
| Technological<br>Characteristics: | The Sternal Closure System possesses the same technological<br>characteristics as the predicate devices. These include:<br>• performance,<br>• implant grade materials, and<br>• basic design.<br>Technological characteristics which are different have been<br>supported with descriptive information and/or performance data.<br>Therefore the fundamental scientific technology of the Sternal<br>Closure System devices is the same as previously cleared devices. |
| Conclusion: | The Sternal Closure System possesses the same intended use and<br>technological characteristics as the predicate devices. Therefore the<br>Sternal Closure System is substantially equivalent for its intended<br>use. |

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