FRAG-LOC SYSTEM

K130986 · Acumed, LLC · HTN · Jul 23, 2013 · Orthopedic

Device Facts

• Record ID: K130986
• Device Name: FRAG-LOC SYSTEM
• Applicant: Acumed, LLC
• Product Code: HTN · Orthopedic
• Decision Date: Jul 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Frag-Loc® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

Device Story

Frag-Loc® System consists of metallic screws, sleeves, and washers; implanted from opposite ends of bone to provide compression across fracture sites, fusions, or osteotomies. Used by orthopedic surgeons in clinical settings to stabilize bone fragments. Device functions as mechanical fixation hardware; provides compression to facilitate healing. Benefits include stable fixation of bone segments.

Clinical Evidence

Bench testing only. Axial pull-out and 4-point bend testing were performed to characterize strength. Results met pre-determined acceptance criteria defined in the Design Control Activities Summary.

Technological Characteristics

System components include screws, sleeves, and washers made of biocompatible metals. Mechanical fixation device; no energy source or software. Dimensions and form factor vary by size. Sterilization method not specified.

Indications for Use

Indicated for patients requiring bone fixation for fractures, fusions, or osteotomies where compression of bone fragments is necessary.

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

• Trans-Osseous Bolt (K982354)

Submission Summary (Full Text)

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| 510(k) Summary | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Frag-Loc® System |
| Manufacturer: | Acumed, LLC<br>5885 NW Cornelius Pass Road<br>Hillsboro, OR 97124 |
| Contact: | Ms. Kara Budor<br>Regulatory Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 22, 2013 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories |
| Class: | II |
| Product Codes: | HTN: HWC |
| JUL 2 3 2013 | |

## Indications For Use:

The Frag-Loo® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

# Device Description:

The Frag-Loc® System consists of various sizes of screws, sleeves, and washers which are implanted from opposite ends of a bone in order to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

### Predicate Device:

The subject Frag-Loc® System is substantially equivalent to the predicate Trans-Osseous Bolt (K982354) with respect to intended use, geometry, and method of fixation. Although the materials in these systems differ, both are made of biocompatible metals and the testing summarized in the Design Control Activities Summary demonstrates that the Frag-Loc® System met the pre-determined acceptance criteria for the verification activities.

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# Preclinical Testing:

The new Frag-Loc® System components were subjected to axial pull-out and 4-point bend testing to characterize their strength. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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Public Health Service

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

July 23, 2013

Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

Re: K130986

Trade/Device Name: Frag-Loc® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: June 7, 2013 Received: June 10, 2013

Dear Ms. Budor:

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 (2 1 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 - Ms. Kara Budor

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Erin |: Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130986

#### Indications for Use 4.

510(k) Number (if known): K130986

Device Name: Frag-Loc® System

The Frag-Loc® System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

ー 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)

Lori A. Wiggins

Division of Orthopedic Devices