AdvantageRib System

K183317 · Sig Medical Corporation · HRS · Feb 14, 2019 · Orthopedic

Device Facts

• Record ID: K183317
• Device Name: AdvantageRib System
• Applicant: Sig Medical Corporation
• Product Code: HRS · Orthopedic
• Decision Date: Feb 14, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Device Story

AdvantageRib System is a thoracoscopic rib fixation and stabilization implant system. It consists of titanium alloy bridges with threaded locking posts and commercially pure titanium locking caps. During surgery, the bridge is placed on the underside of the rib; locking posts extend through pre-drilled holes; locking caps are secured to the posts on the anterior side. The system provides mechanical fixation to stabilize rib fractures or osteotomies. It is intended for use by surgeons in a clinical/OR setting. The device benefits patients by providing rigid fixation to support bone healing and stabilization of the chest wall.

Clinical Evidence

Bench testing only. Dynamic and static mechanical testing of the bridge, locking post, and locking cap construct confirmed performance. Sterilization validation performed per ISO 14937:2009 to achieve a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Materials: Ti-6Al-7N (ASTM F1295), Ti-6Al-4V (ASTM F136, ASTM F1472), Commercially Pure Titanium Grade 4 (ASTM F67). Principle: Mechanical bone fixation via bridge and locking cap construct. Sterilization: Steam sterilization for all implants. Form factor: Thoracoscopic rib plating system.

Indications for Use

Indicated for fixation, stabilization, and fusion of rib fractures and osteotomies in patients with normal or osteoporotic bone.

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

• MatrixRIB Endo Thorascopic Rib Plating System (K141241)

Submission Summary (Full Text)

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February 14, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SIG Medical Corporation % Lauren Smith Project Engineer JALEX Medical, LLC. 30311 Clemens Road, Suite #5D Westlake, Ohio 44145

Re: K183317

Trade/Device Name: AdvantageRib 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 Dated: January 14, 2019 Received: January 15, 2019

Dear Lauren Smith:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Shumaya Ali -S

for 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)

K183317

Device Name AdvantageRib System

Indications for Use (Describe)

The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for SIGMEDICAL. The logo consists of a stylized ribcage on the left, followed by the text "SIG" in black and "MEDICAL" in a light blue color. The ribcage graphic is a simplified representation of the human ribcage, with the sternum and ribs clearly visible.

# 510(k) Summary

| Submitted For: | SIG Medical Corp.<br>238 E. Chocolate Ave. Suite 2<br>Hershey, PA 17033 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/14/2019 |
| Contact Person: | Lauren Smith, Project Engineer, JALEX Medical |
| Contact Telephone: | [phone] |
| Contact Fax: | [phone] |
| Contact Address: | 30311 Clemens Rd. Suite 5D, Westlake, OH 44145 |
| Device Trade Name: | AdvantageRib System |
| Common Names: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Names: | Single/multiple component metallic bone fixation appliances and<br>accessories and Smooth or threaded metallic bone fixation fastener |
| Regulation Numbers: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Regulatory Class: | Class II |
| Product Codes: | HRS, HWC |
| Reviewing Panel: | Orthopedic |
| Primary Predicate Device: | MatrixRIB Endo Thorascopic Rib Plating System (K141241) |

### Device Description:

The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

- Titanium alloy AdvantageRib Bridge with threaded locking posts ●
- . Commercially pure locking caps

When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.

### Indications for Use:

The AdvantageRib System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

### Substantial Equivalence:

The AdvantageRib System has the same intended use, indications for use, principles of operation, and technological characteristics of the predicate. The modifications are not being made as a corrective action for any quality or compliance issues with the predicate version. Modifications summarized in the following table do not raise new questions of safety or effectiveness. Therefore, the AdvantageRib System is substantially equivalent to the predicate.

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Image /page/4/Picture/0 description: The image contains the logo for SIGMEDICAL. The logo features a stylized image of a ribcage on the left. To the right of the ribcage is the text "SIGMEDICAL" in a sans-serif font, with "SIG" in black and "MEDICAL" in a light blue color.

| Item | Modified<br>AdvantageRib System | MatrixRIB Endo<br>Thorascopic Rib Plating<br>System | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HRS, HWC | HRS, HWC | Same |
| Classification<br>Name | Plate, fixation, bone and<br>Screw, fixation, bone | Plate, fixation, bone and<br>Screw, fixation, bone | Same |
| Class | II | II | Same |
| Indications<br>for Use | The AdvantageRib<br>System is intended for<br>the fixation,<br>stabilization, and fusion<br>of rib fractures and<br>osteotomies of normal<br>and osteoporotic bone. | The Synthes Matrix Rib<br>Fixation System is<br>indicated for the fixation<br>and stabilization of rib<br>fractures, fusions and<br>osteotomies of normal and<br>osteoporotic bone. | Same |
| Materials | Bridge (plate) and<br>locking posts: Ti-6Al-<br>7N per ASTM F1295,<br>Ti-6Al-4V per ASTM<br>F136, Ti-6Al-4V per<br>ASTM F1472<br><br>Locking cap and<br>washer: Commercially<br>Pure Titanium Grade 4<br>per ASTM F67 | Plate and locking posts:<br>Ti-6Al-7N per ASTM<br>F1295<br><br>Locking cap:<br>Commercially Pure<br>Titanium Grade 4 per<br>ASTM F67 | The modified<br>AdvantageRib System<br>includes the option of<br>manufacturing the<br>bridges (plates) and<br>locking posts from Ti-<br>6Al-4V per ASTM<br>F136 or Ti-6Al-4V per<br>ASTM F1472. |
| Design<br>Features | Optional washer<br><br>Increased lengths of<br>locking posts and<br>locking caps with<br>internal X-drive feature. | No washer included<br><br>Locking caps with<br>external hex drive feature. | Optional washer<br>distributes the load of<br>tightening the locking<br>posts in poor bone<br>quality.<br><br>Increased length of<br>locking posts allows<br>for increased thread<br>engagement. Locking<br>cap modified drive<br>feature minimizes soft<br>tissue obstruction. |
| Sterilization | Steam Sterilization (All<br>implants and<br>instruments) | Gamma radiation (plates<br>and locking posts), Steam<br>sterilization (locking caps<br>and instruments) | All implants can be<br>steam sterilized and<br>provided non-sterile. |

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Image /page/5/Picture/0 description: The image contains the logo for SIGMEDICAL. To the left of the company name is a grey image of a ribcage. The company name is in all caps, with SIG in black and MEDICAL in a light blue color.

### Non-Clinical Testing:

The AdvantageRib System is identical in geometry and manufacturing process to the predicate device. Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case. Sterilization validation was performed on the subject device per ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices to establish SAL of 10-6.

### Conclusion:

The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate.