SIGN HIP CONSTRUCT (SHC), MODEL: 701

K083582 · Surgical Implant Generation Network (Sign) · KTT · Aug 26, 2009 · Orthopedic

Device Facts

• Record ID: K083582
• Device Name: SIGN HIP CONSTRUCT (SHC), MODEL: 701
• Applicant: Surgical Implant Generation Network (Sign)
• Product Code: KTT · Orthopedic
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

Device Story

SIGN Hip Construct (SHC) is a metallic orthopedic fixation system used for stabilizing peritrochanteric hip fractures. The system comprises an intramedullary Fin Nail, rod plate, rod connector, interlocking screw, compression screws, and a unicortical screw. Used by surgeons in clinical settings to provide mechanical stabilization of bone fractures. The device functions by providing static and dynamic compressive and torsional loading support to the fractured bone, resisting subsidence and expulsion. It is implanted via surgical procedure to facilitate bone healing.

Clinical Evidence

Bench testing only. Mechanical testing performed on the SHC implant demonstrated sufficient strength for static and dynamic compressive and torsional loading modes, as well as resistance to subsidence and expulsion.

Technological Characteristics

Construct consists of stainless steel components (ASTM F138). System includes intramedullary nail, rod plate, rod connector, interlocking screw, compression screws, and unicortical screw. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for patients with peritrochanteric hip fractures, including subtrochanteric fractures. Contraindicated for femoral neck fractures.

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

• SIGN Fin Nail (K043200)
• Holland Femoral Nail System (K983641)
• Synthes Locking Stabilization Plate (K052677)
• Howmedica Omega 3 Trochanteric Stabilization Plate (K081278)
• Howmedica T2 Recon Nail (K051624)
• Synthes CerviFix (K030377)

Submission Summary (Full Text)

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AUG 2 6 2009

## 510(k) Summary of Safety and Effectiveness SIGN Hip Construct (SHC)

| Contact Information | Classification Name: | Appliance, Fixation, Nail/Plate<br>Combination, Multiple Components |
|---------------------------|----------------------|---------------------------------------------------------------------|
| Doug Donnelly | Common Name: | Hip Fixation System |
| 451 Hills Street, Suite B | Proprietary Name: | SIGN Fin Nail |
| Richland, WA 99354 | Regulatory Class: | Class II, OR, 21 CFR §888.3030 |
| Phone: [phone] | Product Codes: | KTT, HSB, HRS |
| Fax: [phone] | | |
| [e-mail] | | |

### Substantial Equivalence Information

The SIGN Hip Construct (SHC) is similar to the following predicate devices:

- SIGN Fin Nail (K043200) .
- Holland Femoral Nail System (K983641) .
- Synthes Locking Stabilization Plate (K052677) �
- Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) ●
- Howmedica T2 Recon Nail (K051624) ●
- Synthes CerviFix (K030377) ●

All of the devices listed above are similar in both their intended use and the basic concept by which they are used. The safety and effectiveness of the SHC is also based on a long history of use of this type of device in the marketplace.

## Device Description

The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.

#### Indications for Use

Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

### Performance Data

Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Surgical Implant Generation Network (SIGN), Inc. % Mr. Doug Donnelly Manager, Regulatory Affairs 451 Hills Street, Suite B Richland, WA 99354

# AUG 2 6 2009

Re: K083582

Trade/Device Name: SIGN Hip Construct (SHC) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HSB, HRS Dated: July 29, 2009 Received: August 4, 2009

Dear Mr. Donnelly:

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.

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. Doug Donnelly

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely, yours,

Boban Buchm

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

510(k) Number (if known): K083582

Device Name: SIGN Hip Construct (SHC)

Indications For Use: .

Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue This does not include femoral neck fractures and may management . include subtrochanteric fractures.

X Prescription Use (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)

Sanita Lo mxm
(Division Sign Off)

(Division Sign-Of Division of Surgical, Orthope and Restorative Devices

510(k) Number K083582

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