(111 days)
Not Found
No
The summary describes a mechanical internal fixation system made of titanium alloy. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are benchtop mechanical tests and finite element analysis, not studies related to algorithmic performance.
Yes
The device is described as an "Internal Fixation System" intended for "alignment and stabilization of small bone fractures" and other medical procedures like "Ligament reconstruction," "Arthrodesis," and "Osteotomies." These uses directly address the treatment and restoration of bodily functions.
No.
The device is described as an internal fixation system used for alignment and stabilization of small bone fractures and other orthopedic procedures; it does not perform any diagnostic functions.
No
The device description explicitly states it is comprised of physical components (Cannulated Headed and Headless Screws and Hook Plates) fabricated from titanium alloy, which are implantable hardware.
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. These tests are performed outside of the body.
- Device Description: The description clearly states that this device is an "Internal Fixation System" comprised of "implantable components" (screws and plates) made of titanium alloy. These components are surgically implanted inside the body to stabilize bone fractures and perform other orthopedic procedures.
- Intended Use: The intended use is for "alignment and stabilization of small bone fractures" and other orthopedic procedures, all of which involve surgical intervention and placement of the device within the body.
The information provided describes a surgical implant, not a device used for testing biological samples in a laboratory setting.
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, 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 osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws and Hook Plates intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (6AI-4V-ELI per ASTM F 136). Screws and hook plates 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 non-threaded portion facilitates compression of the joint surfaces through a lag technique. The low profile hook plate can provide interfragmentary compression and is well suited for areas of limited soft tissue coverage.
All implants are 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
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)
Static and Dynamic Compression and Torsion testing in accordance with ASTM F543, Benchtop Testing. Finite Element Analysis and Engineering rationale was presented to demonstrate the substantial equivalency of the Life Spine Cannulated Screw System.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2015
Life Spine, Inc. Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K150126
Trade/Device Name: Life Spine Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: April 13, 2015 Received: April 14, 2015
Dear Mr. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/Resourcesfor You/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 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 vours.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150126
Device Name Life Spine Cannulated Screws
| 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, 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 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
Life Spine Cannulated Screw System
| Submitted By: | Life Spine
13951 S Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
General Manager
Life Spine
13951 S Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | May 4th, 2015 |
| Trade Name: | Life Spine Cannulated Screw System |
| Classification: | HWC, CFR 888.3040, Class II
HRS, CFR 888.3030, Class II |
| Primary Predicate Device:
Predicate Devices: | Biomet BioDrive Micro Screw (K092670)
Synthes Cannulated Screw (K963192)
ACE Medical Cortical Screw (K905048) |
Device Description:
The Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws and Hook Plates intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (6AI-4V-ELI per ASTM F 136). Screws and hook plates 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 non-threaded portion facilitates compression of the joint surfaces through a lag technique. The low profile hook plate can provide interfragmentary compression and is well suited for areas of limited soft tissue coverage.
All implants are 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.
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Intended 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 Life Spine Cannulated Screw System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.
Material:
The Life Spine Cannulated Screw System is manufactured from implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.
Performance Data:
Static and Dynamic Compression and Torsion testing in accordance with ASTM F543, Benchtop Testing. Finite Element Analysis and Engineering rationale was presented to demonstrate the substantial equivalency of the Life Spine Cannulated Screw System.
Conclusion:
The Life Spine Cannulated Screw System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.