HAMMERLOCK 2

K133520 · Biomedical Enterprises, Inc. · HTY · Jan 9, 2014 · Orthopedic

Device Facts

• Record ID: K133520
• Device Name: HAMMERLOCK 2
• Applicant: Biomedical Enterprises, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Jan 9, 2014
• 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 inter-digital fusion of fingers and toes.

Device Story

HammerLock® 2 is a nitinol intramedullary bone fastener used for finger and toe reconstruction and fusion. The device is inserted into the intramedullary space of small bones; upon reaching body temperature, the nitinol legs deflect outward to provide anchoring force. It is used by surgeons in a clinical setting. The device provides mechanical fixation to facilitate bone fusion. It is stored at room temperature, unlike its predecessor which required freezing. The device is available in straight and 10-degree angled styles.

Clinical Evidence

Bench testing only. Mechanical bending parameters compared to predicate using ASTM F382-99; results showed HammerLock® 2 exceeds predicate stiffness and strength. Corrosion resistance evaluated using ASTM F2129-08, demonstrating adequacy and equivalence to predicate SmartToe devices.

Technological Characteristics

Nitinol (ASTM F2063-05) intramedullary fastener. Thermal shape-memory actuation at body temperature. Available in 17, 20, 22, 25 mm lengths; straight and 10-degree angled styles. Mechanical fixation via outward leg deflection. Bench testing per ASTM F382-99 (mechanical bending) and ASTM F2129-08 (corrosion).

Indications for Use

Indicated for small bone reconstruction and fusion, specifically inter-digital fusion of 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

• BME HammerLock® (K131640)

Reference Devices

• SmartToe (K070598)

Submission Summary (Full Text)

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### (510(k) Summary)

JAN - 9 2014

Product: HammerLock® 2

Submitter Information

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

Date Prepared: October 31, 2013

Classification name: Smooth or Threaded Metallic Bone Fastener (21 CFR 888.3040)

Classification: Class II Product Code: HTY Common/Usual Name: Intramedullary Bone Fastener Proprietary Name: HammerLock® 2

#### Intended Use:

The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

#### Substantial Equivalence:

The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock® cleared in K131640.

#### Device Description

The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force.

The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

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| Product Name: | HammerLock® 2<br>New device | Predicate<br>HammerLock® (K131640) |
|---------------------------|------------------------------------------|------------------------------------------|
| Raw Material: | Nitinol, per ASTM<br>F2063-05 | Nitinol, per ASTM<br>F2063-05 |
| Sizes: | 17, 20, 22, and 25 mm | 12, 14, 16, 19, 22 mm |
| Styles: | Straight and 10 degree Angled | Straight and 10 degree angled |
| Pre-Operative<br>Storage: | Room temperature | Must be frozen prior to use |
| Heat Source: | Fully transformed<br>at body temperature | Fully transformed at body<br>temperature |

Technological Characteristics Comparison to the Predicates

#### Implant Dimensions:

The new HammerLock® 2 device is longer than the predicate K131640 HammerLock®. The length is added to the proximal side of the implant (the portion designed to be inserted into the proximal phalanx). The extended proximal length of the HammerLock® 2 allows for better fixation.

#### Performance Bench Testing:

Standard ASTM F382-99 was used to compare the mechanical bending parameters of the new HammerLock® 2 to the predicate K131640 HammerLock®. The results showed that all of the new HammerLock® 2 designs exceed the stiffness and strength of the predicate.

Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new HammerLock® 2 to technical literature and to predicate SmartToe devices (K070598). Test results demonstrate that the HammerLock® corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.

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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

January 9, 2014

BioMedical Enterprises, Incorporated Mr. Joe W. Soward Director, Quality, Compliance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K133520

Trade/Device Name: HammerLock® 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: November 7, 2013 Received: November 15, 2013

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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#### Page 2 - Mr. Joe W. Soward

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 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" (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronaldingean -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): K133520

Device Name: HammerLock® 2

Indications For Use:

The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

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)

Page 1. of

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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