(256 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as a "Hammertoe Correction System" and its intended use is for "small bone reconstruction limited to inter-digital repair and fusion of the lesser toes," which indicates a therapeutic purpose to correct a medical condition.
No
The device is described as a "2-Piece Hammertoe Correction System" intended for "small bone reconstruction limited to inter-digital repair and fusion of the lesser toes," indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states it is a "two-piece construct" fabricated from Titanium, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that the 2-Piece Hammertoe Correction System is a surgical implant made of titanium that is inserted into the body to stabilize a joint in the toe.
- Intended Use: The intended use is for "small bone reconstruction limited to inter-digital repair and fusion of the lesser toes," which is a surgical procedure performed on the body.
This device is a surgical implant, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Product codes
HWC
Device Description
The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inserted in the proximal and middle phalanges, so that each implants threads fixate on the phalangeal canal of the toe and stabilize the joint. The implant is fabricated and manufactured from the following:
- Titanium (Ti 6A1-4V ELI)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inter-digital repair and fusion of the lesser toes (small bone reconstruction)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System.
Key Metrics
Not Found
Predicate Device(s)
Arthrosurface Hammertoe Correction System (K130859), Hammertoe Correction System (K153065), Wright Medical PhaLinx (K142585), Arthrex BioPin (K050259), Gramedica Opti-Toe (K142478), Pioneer Surgical Technology Stayfuse (K990804, K022726)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2017
Life Spine, Inc. Randy Lewis General Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K162685
Trade/Device Name: 2-piece Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2017 Received: May 12, 2017
Dear Randy Lewis:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
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) K162685
Device Name
2-Piece Hammertoe Correction System
Indications for Use (Describe)
The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 2-Piece Hammertoe Correction System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | May 11th, 2017 |
| Trade Name: | 2-Piece Hammertoe Correction System |
| Common Name: | Intramedullary Bone Screw |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | HWC, CFR 888.3040, Class II |
| Primary Predicate: | Arthrosurface Hammertoe Correction System (K130859) |
| Secondary Predicate: | Hammertoe Correction System (K153065)
Wright Medical PhaLinx (K142585)
Arthrex BioPin (K050259)
Gramedica Opti-Toe (K142478)
Pioneer Surgical Technology Stayfuse (K990804, K022726) |
Device Description:
The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inserted in the proximal and middle phalanges, so that each implants threads fixate on the phalangeal canal of the toe and stabilize the joint. The implant is fabricated and manufactured from the following:
- Titanium (Ti 6A1-4V ELI)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.
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K162685 PAGE 2 OF 2
Indications for Use of the Device:
The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Technological Characteristics:
The 2-Piece Hammertoe Correction System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.
Material:
The 2-Piece Hammertoe Correction System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of non-sterile titanium, single use components.
Performance Data:
Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System.
Conclusion:
The information presented demonstrates the substantial equivalency of the 2-Piece Hammertoe Correction System.