(55 days)
No
The summary describes a mechanical implant and instrumentation with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for small bone reconstruction and fusion, which is a therapeutic purpose to treat a medical condition (bone damage or deformity).
No
The device is described as an implant used for small bone reconstruction and fusion, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the HammerLock® 2 is a nitinol implant and includes new disposable instrumentation, indicating it is a physical medical device, not software-only.
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® 2 Function: The description clearly states the HammerLock® 2 is an implant used for surgical fixation within the body (intramedullary fixation of fingers and toes). It is a physical device inserted into the patient, not a test performed on a sample outside the body.
The information provided describes a surgical implant and its mechanical performance, which is consistent with a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.
Product codes
HTY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone, inter-digital, fingers, 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 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.
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)
JAN - 9 2014
Product: HammerLock® 2
Submitter Information
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Fax: (210) 677-0355 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.
1
| Product Name: | HammerLock® 2
New device | Predicate
HammerLock® (K131640) |
|---------------------------|------------------------------------------|------------------------------------------|
| Raw Material: | Nitinol, per ASTM
F2063-05 | Nitinol, per ASTM
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
Storage: | Room temperature | Must be frozen prior to use |
| Heat Source: | Fully transformed
at body temperature | Fully transformed at body
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.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The text is centered on the image and takes up most of the space.
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 pattern around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
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
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" (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 (800) 638 2041 or (301) 796-7100 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
4
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
4-1