OPTOSSOL COMPRESSION DEVICE SYSTEM

K140875 · Genossis, LLC · JDW · May 30, 2014 · Orthopedic

Device Facts

• Record ID: K140875
• Device Name: OPTOSSOL COMPRESSION DEVICE SYSTEM
• Applicant: Genossis, LLC
• Product Code: JDW · Orthopedic
• Decision Date: May 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.

Device Story

OptOssol™ Compression Device System consists of metallic screws and wires designed to compact juxtaposed bone fragments; provides compression to enhance bone healing and fusion via immobilization of fragments; may be used with or without bone graft. Wires inserted using standard OR wire drivers; compression applied via provided driver. Partially threaded wires available with sleeve in various diameters/lengths to accommodate patient anatomy. Used in OR by surgeons (hand, orthopedic, podiatric). Output is physical stabilization of bone fragments; aids clinical decision-making by providing mechanical fixation for healing. Benefits patient by promoting bone fusion and fracture stability.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F543:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws.

Technological Characteristics

Implants: 316 LVM Stainless Steel (ASTM F138). Instruments: 17-4PH Stainless Steel and Custom 465® Stainless Steel (ASTM F899). Mechanical fixation via compression screws/wires. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for internal fixation of fractures, fusions, and revisions in hand, orthopedic, and podiatric surgery. Not for spinal use.

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

• K130298

Submission Summary (Full Text)

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### MAY 3 0 2014

K140875 page 1 of 2

## 510(k) SUMMARY

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### GenOssis, LLC

## OptOssol™ Compression Device Systeṃ

| Sponsor: | Manufacturer | GenOssis LLC<br>426 Pennsylvania Avenue, Suite 120<br>Fort Washington, PA 19034 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | Official Contact<br>Phone:<br>Fax: | Barry E. Sands<br>978-358-7307<br>978-358-7384 |
| | Date prepared: | April 1, 2014 |
| Device Name: | OptOssol™ Compression Device System | |
| Classification<br>Name: | Smooth or Threaded Metallic Bone Fixation Fastener<br>Single/multiple Component Metallic Bone Fixation Appliances and<br>Accessories | |
| Classification<br>Number: | 21 CFR Sec. 888.3030 and 21 CFR 888.3040<br>Class 2<br>Product Code: HTN, JDW and HWC | |
| Description: | The GenOssis OptOssol™ Compression Device System implants consists of screws<br>designed to compact juxtaposed bone fragments in compression to enhance bone<br>healing and fusion through the immobilization of the fragments with or without the<br>use of bone graft. The wires are inserted using standard wire drivers present in the<br>operating room and compression is conducted using the provided driver.<br>The partially threaded Wires are available with a Sleeve, and in various diameters<br>and lengths to accommodate patient anatomy. | |
| Intended Use: | The OptOssol™ Compression Device System is indicated for use in the internal<br>fixation of fractures, fusions and revisions, The system is intended for but not<br>limited to hand surgery, orthopedic surgery and podiatric surgery - but is not<br>intended for Spinal Use. | |
| Material: | The OptOssol™Compression Device System is composed of 316 LVM ASTM F138.<br>The material composition has been established as a biocompatible material for<br>orthopedic permanent implants | |

April 2, 2014

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| | The instruments associated with the OptOssol™ Compression Device System are<br>composed of 17-4PH Stainless Steel and Custom 465® Stainless Steel (ASTM F899).<br>Both of these tissue-contacting materials have an established biocompatible profile<br>for surgical instruments in orthopedics. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate<br>Devices | OptOssol™ Compression Device System has the same intended use as the predicate<br>device contained in K130298. The technological characteristics of material<br>composition and dimensional specifications fall within the range of the predicate<br>devices identified. Therefore, the OptOssol™ Compression Device System is<br>equivalent to the predicate devices identified. |
| Performance<br>Data: | Mechanical tesing was performed per ASTM F543:2013 Standard Specification and<br>Test Methods for Metallic Medical Bone Screws. |
| Performance<br>and SE<br>Determination: | Based upon the results of the performance testing the OptOssol™ Compression<br>Device System was determined to be substantially equivalent to the predicate<br>devices. |

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April 2, 2014

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 30, 2014

GenOssis. LLC % Mr. Barry E. Sands RQMIS, Incorporated 29 Water Street. Suite 305 Newburyport, Massachusetts 01950

Re: K140875

. Trade/Device Name: GenOssis OptOssol™ Compression Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTN, HWC Dated: April 2. 2014 Received: April 4, 2014

Dear Mr. Sands:

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 (sec above) into cither 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. Barry E. Sands

forth in the quality systems (QS) regulation (R1 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/ResourcesforYou/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/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 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.

Sincercly vours.

## Ronald P. Jean -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 Statement

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K140875 510(k) Number (if known):_

Device Name: GenOssis OptOssol™ Compression Device System

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Indications for Use:

The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.

OR

Prescription Use _ X (Per 21 CFR 801.109) Over-the-Counter Use _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Elizabeth lägrank -S

Division of Orthopedic Devices

GenOssis, Inc. OptOssol™ Compression Device System April 2, 2014