Life Spine Cannulated Screws

K150126 · Life Spine, Inc. · HWC · May 11, 2015 · Orthopedic

Device Facts

• Record ID: K150126
• Device Name: Life Spine Cannulated Screws
• Applicant: Life Spine, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Device Story

System consists of cannulated headed/headless screws and hook plates for small bone fixation; used for alignment/stabilization of bone fragments in articular regions. Screws feature differential thread pitch for interfragmentary compression; non-threaded portion facilitates lag technique. Hook plates provide compression in areas with limited soft tissue. Components are non-sterile, single-use, titanium alloy implants. Used by surgeons in clinical settings for orthopedic procedures. Benefits include stabilization of fractures/osteotomies and support for joint arthrodesis.

Clinical Evidence

Bench testing only. Static and dynamic compression and torsion testing performed in accordance with ASTM F543. Finite element analysis and engineering rationale provided to demonstrate substantial equivalence.

Technological Characteristics

Manufactured from titanium alloy (Ti 6Al-4V ELI) per ASTM F136. System includes cannulated headed/headless screws and hook plates. Mechanical performance validated via ASTM F543 testing. Non-sterile, single-use components.

Indications for Use

Indicated for alignment and stabilization of small bone fractures in foot, ankle, wrist, elbow, and hand. Includes treatment of fractures, non-unions, mal-unions, ligament reconstruction, osteochondritis dissecans, arthrodesis, and osteotomies resulting from trauma, deformity, osteoarthritis, or rheumatoid arthritis.

Regulatory Classification

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.

Predicate Devices

• Biomet BioDrive Micro Screw (K092670)
• Synthes Cannulated Screw (K963192)
• ACE Medical Cortical Screw (K905048)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>13951 S Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>General Manager<br>Life Spine<br>13951 S Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | May 4th, 2015 |
| Trade Name: | Life Spine Cannulated Screw System |
| Classification: | HWC, CFR 888.3040, Class II<br>HRS, CFR 888.3030, Class II |
| Primary Predicate Device:<br>Predicate Devices: | Biomet BioDrive Micro Screw (K092670)<br>Synthes Cannulated Screw (K963192)<br>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.