(146 days)
No
The device description and performance studies focus on mechanical properties and physical components, with no mention of AI, ML, or image processing.
Yes
This device is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges, which falls under the definition of a therapeutic purpose.
No
The device is a fusion and stabilization system for phalangeal fractures, fusions, and osteotomies, not a tool for diagnosis.
No
The device description clearly states it is composed of physical components (counter rotation ring implant, recovery dowel, K-wire) and performance studies involve mechanical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges." This describes a surgical implant used directly on the patient's body for structural support and healing.
- Device Description: The description details a physical implant (counter rotation ring, recovery dowel, K-wire) used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used within the body.
N/A
Intended Use / Indications for Use
The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
Product codes (comma separated list FDA assigned to the subject device)
HTY, JDW
Device Description
The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges
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)
The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459).
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
September 14, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Intelivation % Barry Sands CEO and Founder Ramis 110 Haverhill Road Suite 524 Amesbury, Massachusetts 01913
Re: K231147
Trade/Device Name: Hammerdesis™ Interphalangeal Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: August 8. 2023 Received: August 16, 2023
Dear Mr. Sands:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eileen
Digitally signed
by Eileen Cadel
-S
Cadel -S Date:
2023.09.14
16:21:29-04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231147
Device Name
Hammerdesis™ Interphalangeal Fusion System
Indications for Use (Describe)
The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
Intelivation's Hammerdesis™ Interphalangeal Fusion System
Date Prepared: September 13, 2023
l. Submitter, Author, and Contact Person
Intelivation
David Posillico 500 S. Gravers Rd., Suite 200 Plymouth Meeting, PA 19462 Phone: 912-434-2780 Email: dposillico@intelivationtech.com
Author:
Taylor Gold West Sr. Regulatory Affairs Consultant Phone: 978-358-7307 Email: regulatorysubmissions@rqmis.com
Primary Contact:
Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: (978) 358-7307 Email: regulatorysubmissions@rqmis.com
II. Subject Device
| Trade/proprietary name of device: | Hammerdesis™ Interphalangeal Fusion System |
|---|---|
| Common or Usual Name: | Counter rotational ring (sm/lg), K-wire |
| Classification Name: | Pin, Fixation, Smooth |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II |
| Product Code: | HTY |
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III. Predicate Device
Primary Predicate:
| 510(k) Number: | K190287 |
|---|---|
| Trade/proprietary name of device: | Arthrex DynaNite PIP (Hammertoe) Implant |
| Applicant: | Arthrex Inc. |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II |
| Product Code: | HTY |
Reference Device:
| 510(k) Number: | K131459 |
|---|---|
| Trade/proprietary name of device: | AAP K-Wire, Steinmann Pin, Cerclage Wire |
| Applicant: | AAP Implantate AG |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II |
| Product Code: | JDW (subsequent code: HTY) |
| 510(k) Number: | K191243 |
| Trade/proprietary name of device: | HEDRON Cervical Spacers |
| Applicant: | Globus Medical Inc. |
| Regulation Number: | 888.3080 Intervertebral body fusion device |
| Classification: | Class II |
| Product Code: | ODP, OVE |
| 510(k) Number: | K192417 |
| Trade/proprietary name of device: | ARIX Cannulated Screw System |
| Applicant: | Jeil Medical Corporation |
| Regulation Number: | 888.3040: Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II |
| Product Code: | HWC |
Device Description IV.
The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The
5
counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.
V. Indications for Use
The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
VI. Technological Characteristics
The Hammerdesis™ Interphalangeal Fusion System is composed of a counter rotation ring (small or large), recovery dowel and K-wire. The subject device implants are composed of Ti-6Al-4V per ASTM F3001-14 and stainless steel per ASTM F138.
The manufacturer produces all instrumentation from surgical grade stainless steel per traditional manufacturing methods.
VII. Performance Data
The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459).
VIII. Sterility
The Hammerdesis™ Interphalangeal Fusion System is provided non-sterile and is intended to be end-user sterilized before use.
IX. Conclusion
The technological differences between the subject device and the primary (K190287) and reference predicates (K131459, K191243, K192417) do not raise new questions of safety and effectiveness. Any differences in technological characteristics have been tested and documented. The subject device and predicates (K190287, K131459, K192417) have been determined to be substantially equivalent in terms of indications for use, materials, performance, sterility, and biocompatibility.