(134 days)
No
The description focuses on the material properties (nitinol) and mechanical function of the implant, with no mention of AI or ML.
Yes
The device is indicated for "Small bone reconstruction and fusion," which is a therapeutic purpose. It is an implant designed to provide intramedullary fixation.
No
The device is described as an implant for bone reconstruction and fusion, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a nitinol implant, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- HammerLock function: The HammerLock is an implantable device used for surgical fixation of bones in fingers and toes. It is physically placed inside the body to provide structural support and promote fusion.
- Lack of testing on samples: The description clearly states the device is an implant and its function is based on its physical properties and interaction with bone tissue within the body, not on analyzing samples outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Hammerlock is indicated for: Small bone reconstruction and fusion such as interdigital fusion of fingers and toes.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force.
This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing: Standard ASTM F382-99 was used to compare the mechanical bend test parameters of the new Hammerlock to the predicate K091951 Hammerlock. The results showed that all of the new Hammerlock designs were substantially equivalent to 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 to technical literature and to predicate SmartToes devices (K070598). The test results demonstrate that the Hammerlock corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
(510(k) Summary)
K131640
Product: HammerLock
Submitter Information
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245
OCT 1 6 2013
| Telephone: | (210) 677-0354 |
|---|---|
| Fax: | (210) 677-0355 |
| Contact: | Joe W. Soward |
| Date Prepared: | September 12, 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 |
Intended Use:
The Hammerlock is indicated for: Small bone reconstruction and fusion such as interdigital fusion of fingers and toes.
Substantial Equivalence:
The upgraded Hammerlock is substantially equivalent to the predicate BME Hammerlock cleared in K091951.
Device Description
The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock
device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force.
This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.
1
Technological Characteristics Comparison to the Predicates:
| Product Name: | Upgraded Hammerlock | Predicate Hammerlock
(K091951) |
|------------------------|------------------------------------------|------------------------------------------|
| Raw Material: | Nitinol, per ASTM F2063-05 | Nitinol, per ASTM F2063-05 |
| Sizes: | 12,14,16,19,22 mm | 16,19,22 mm |
| Styles: | Straight and 10 degree
Angled | Straight |
| Pre-Operative Storage: | Must be frozen prior to use | Must be frozen prior to use |
| Heat Source: | Fully transformed at body
temperature | Fully transformed at body
temperature |
Performance Bench Testing:
Standard ASTM F382-99 was used to compare the mechanical bend test parameters of the new Hammerlock to the predicate K091951 Hammerlock. The results showed that all of the new Hammerlock designs were substantially equivalent to 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 to technical literature and to predicate SmartToes devices (K070598). The test results demonstrate that the Hammerlock corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the heading of a document or a sign. The font is sans-serif and the text is black.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2013
BioMedical Enterprises. Incorporated Mr. Joe Soward Director, Quality Assurance/Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K131640
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: September 19, 2013 Received: September 20, 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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
WARNING: THIS PRODUCT CONTAINS A CHEMICAL KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.
Sincerely yours,
Erini Joeith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K131640 |
|---|---|
| Device Name: | HammerLock® |
| Indications For Use: | The HammerLock® 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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1