HAMMERLOCK

K091951 · Biomedical Ent., Inc. · HTY · Feb 19, 2010 · Orthopedic

Device Facts

• Record ID: K091951
• Device Name: HAMMERLOCK
• Applicant: Biomedical Ent., Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HammerLock™ is indicated for small bone reconstruction and fusion such as in the phalanges of the fingers and toes.

Device Story

Intramedullary bone fixation device for small bone reconstruction/fusion. Device placed in intramedullary space; prongs extend into cancellous bone. Transformation to final configuration triggered by body heat; prongs deflect outward to create compressive force. Two models: X-Type and Loop. Used by physicians in clinical settings. Provides mechanical stabilization to facilitate bone fusion.

Clinical Evidence

Bench testing only; no clinical data provided. Performance compared to predicate devices.

Technological Characteristics

Metallic bone fastener; intramedullary design. Utilizes shape-memory properties for configuration change via body heat. Prongs deflect outward to provide compressive force. Class II device.

Indications for Use

Indicated for small bone reconstruction and fusion, specifically inter-digital fusion of phalanges in fingers and toes.

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

• Memometal Technologies (MMI-USA) SmartToe™

Submission Summary (Full Text)

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091951 (pg 1/2)

#### (510(k) Summary)

# FEB 1 9 2010

#### OSSplate™ HammerLockTM Product:

BioMedical Enterprises, Inc. (BME) intends to introduce an addition to the OSSplate™ line of the OSStaple™ Staple System.

Submitter Information

BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: [phone] Contact: Joe W. Soward

Date Prepared: June 26, 2009

Classification name:

Common/Usual Name: Proprietary Name:

Smooth or Threaded Metallic Bone Fastener Intramedullary Bone Fastener Hammerlock™

Intended Use:

The HammerLock™ is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

#### Device Description

The HammerLock™ is an addition to the OSSPlate™ line and is designed for use as an intramedullary bone fixation device. The OSSPlate™ is situated on the bone with the prongs extending through the cortex and in its final configuration the prongs are deflected inward to create a clamping force. With the HammerLock™ the device is situated in the intramedullary space with the prongs extending into the cancellous bone and in the final configuration the prongs are deflected outward to create a compressive force. Two models of the HammerLock™ are provided for physician choice, the HammerLock™ X-Type and HammerLock™ Loop. Both exhibit similar test results to the predicate devices. The HammerLock™ models transformed to their final configuration by body heat alone.

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### Substantial Equivalence:

The HammerLock™ is substantially equivalent to Memometal Technologies (MMI-USA) SmartToe™.

The FDA has classified these equivalent devices as Class II devices (e.g. 21 CFR, 888.3040). The HammerLock™ is a Class II medical device.

(Signature)

Joe W. Soward Director, Quality Assurance and Regulatory Affairs BioMedical Enterprises, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national bird, with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

### FEB 1 9 2010

Biomedical Ent., Inc. % Mr. Joe W. Soward 14785 Omicron Dr., Suite 205 San Antonio, Texas 78245

Re: K091951

Trade/Device Name: HammerLock™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: December 15, 2009 Received: December 16, 2009

Dear Mr. Soward:

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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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,
Mark M Milkersen

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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Device Name: Hammerlock

## Indications for Use

The HammerLock™ is indicated for small bone reconstruction and fusion such as in the phalanges of the fingers and toes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use イ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Soneta for mxn
(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K091951