(59 days)
No
The 510(k) summary describes a mechanical fixation system (screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an implantable fixation system to align and stabilize bone fractures, which is a supportive rather than a therapeutic function.
No
The device is described as an internal fixation system used for alignment and stabilization of small bone fractures and other orthopedic procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is comprised of "Cannulated Headed and Headless Screws" fabricated from titanium alloy, which are physical hardware components.
Based on the provided information, 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, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states that the Cannulated Screw Internal Fixation System is an implantable device used for the internal fixation and stabilization of bone fractures and other musculoskeletal issues. It is surgically placed inside the body.
The device's function is mechanical support and stabilization within the body, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:
• Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, or mal-unions
• Ligament reconstruction
• Osteochondritis dissecans
• Arthrodesis of the foot, ankle, wrist, elbow and hand
• Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Product codes
HWC
Device Description
The Life Spine Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (Ti 6A1-4V-ELI per ASTM F 136). Screws offer a variety of sizes of non-sterile, single-use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The nonthreaded portion facilitates compression of the joint surfaces through a lag technique.
All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation 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
small bones, such as those in the foot, ankle, wrist, elbow and hand
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)
Mechanical testing according to ASTM F543 including Static Axial Pull-Out & Static Torsion was presented to demonstrate substantial equivalence of the Cannulated Screw Internal Fixation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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December 14, 2017
Life Spine, Inc. Randy Lewis General Manger 13951 South Quality Drive Huntley, Illinois 60142
Re: K173286
Trade/Device Name: Cannulated Screw Internal Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 3, 2017 Received: October 16, 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
1
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K173286
Device Name
Cannulated Screw Internal Fixation System
Indications for Use (Describe)
The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:
· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, or mal-unions
• Ligament reconstruction
- · Osteochondritis dissecans
· Arthrodesis of the foot, ankle, wrist, elbow and hand
· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
| 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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| 510(k) Summary |
|---|
| Cannulated Screw Internal Fixation 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: | October 3rd, 2017 |
| Trade Name: | Cannulated Screw Internal Fixation System |
| Regulation Name:
Common Name:
Classification: | Smooth or Threaded Metallic Bone Fixation Fastener
Screw, Fixation, Bone
HWC, CFR 888.3040, Class II |
| Primary Predicate: | BioPro Cannulated Go-Ez Screws K081149 |
| Secondary Predicate: | Vilex Small Headless Screw K014154
Biomet Biodrive Micro Screw System K092670 |
| Reference Device: | Life Spine Cannulated Screws K150126 |
Device Description:
The Life Spine Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (Ti 6A1-4V-ELI per ASTM F 136). Screws offer a variety of sizes of non-sterile, single-use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The nonthreaded portion facilitates compression of the joint surfaces through a lag technique.
All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation System components should never be reused under any circumstances.
4
Indications for Use of the Device:
The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of ● fractures, non-unions, or mal-unions
- Ligament reconstruction
- Osteochondritis dissecans ●
- Arthrodesis of the foot, ankle, wrist, elbow and hand ●
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Technological Characteristics:
The Cannulated Screw Internal Fixation System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.
Material:
The Cannulated Screw Internal Fixation System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of non-sterile titanium, single use components.
Performance Data:
Mechanical testing according to ASTM F543 including Static Axial Pull-Out & Static Torsion was presented to demonstrate substantial equivalence of the Cannulated Screw Internal Fixation System.
Conclusion:
The information presented demonstrates substantial equivalence of the Cannulated Screw Internal Fixation System.