Life Spine Foot and Ankle Plating System

K172973 · Life Spine, Inc. · HRS · Dec 21, 2017 · Orthopedic

Device Facts

• Record ID: K172973
• Device Name: Life Spine Foot and Ankle Plating System
• Applicant: Life Spine, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures, joint fusions, and reconstruction of the bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

Device Story

System of metallic plates and screws for orthopedic fixation and reconstruction of foot and ankle bones. Implants provide stabilization for fractures, osteotomies, and joint fusions. Used by surgeons in clinical/OR settings. Surgeon selects appropriate plate/screw configuration to fixate bone segments; provides mechanical stability to facilitate healing. Benefits include structural support for bone reconstruction and fracture management.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including Finite Element Analysis, engineering rationale, and mechanical validation of torsional strength, bending strength, and axial pullout.

Technological Characteristics

Materials: Titanium (Ti-6Al-4V-ELI per ASTM F136) and Stainless Steel (316L per ASTM F138). Design: Plating system with plurality of screw holes for bone fixation. Single-use implants.

Indications for Use

Indicated for stabilization and fixation of fractures, osteotomies, intra/extra-articular fractures, joint depression, multifragmentary fractures, joint fusions, and reconstruction of small bones of toes, feet, and ankles (including distal tibia, talus, calcaneus) in adult and pediatric patients.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Paragon 28 Paralock Plating System / Tuffnek Screw (K140397)
• Depuy ALPS Small Bone Locked Plating System (K101240)
• Ortho Solutions Extremity Fixation Implants for osteosynthesis (K111678)
• Life Spine Opening Base Wedge (K161037)

Submission Summary (Full Text)

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December 21, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Life Spine Inc. Randy Lewis General Manager 13951 S Quality Drive Huntlev, Illinois 60142

Re: K172973

Trade/Device Name: Life Spine Foot and Ankle Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 20, 2017 Received: November 8, 2017

Dear Randy Lewis:

We have reviewed vour 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 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.

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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 ([e-mail]) or phone [phone] 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) K172973

#### Device Name

Life Spine Foot and Ankle Plating System

#### Indications for Use (Describe)

The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures, joint fusions, and reconstruction of the bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

Type of Use (*Select one or both, as applicable*):

| <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary Life Spine Foot and Ankle Plating System

| Submitted By: | Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | September 22nd, 2017 |
| Trade Name: | Life Spine Foot and Ankle Plating System |
| Common Name: | Plate, Fixation, Bone |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and<br>accessories |
| Classification: | HRS, CFR 888.3030, Class II<br>HWC, CFR 888.3040, Class II |
| Primary Predicate: | Paragon 28 Paralock Plating System / Tuffnek Screw (K140397) |
| Secondary Predicate: | Depuy ALPS Small Bone Locked Plating System (K101240)<br>Ortho Solutions Extremity Fixation Implants for osteosynthesis (K111678)<br>Life Spine Opening Base Wedge (K161037) |

## Device Description:

The Life Spine Foot and Ankle Plating System is system of plates and screws for fixation and reconstruction of the foot and ankle. The implant is fabricated and manufactured from the following:

- 1) Titanium (Ti 6A1-4V ELI)
- 2) Stainless Steel (316L)

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All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Foot and Ankle Plating System components with components from any other system or manufacturer. The Foot and Ankle Plating System components should never be reused under any circumstances.

### Indications for Use of the Device:

The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusion and reconstructions of small bones of the toes, feet, and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

## Technological Characteristics:

The Life Spine Foot and Ankle Plating System are comparable in design and technological characteristics to one or more predicate devices. All plates utilize a plurality of screw holes to fixate the plate to bone using screws.

## Material:

The Life Spine Foot and Ankle Plating System is Ti-6AL-4V-ELI titanium manufactured according to ASTM F136 and Stainless Steel 316L manufactured according to ASTM F138. Devices are single use implants.

## Performance Data:

Finite Element Analysis, Engineering Rationale and Bench Top Validations were included to demonstrate the substantial equivalency of the Life Spine Foot and Ankle Plating System with respect to: torsional strength, bending strength and axial pullout.

## Conclusion:

The information presented demonstrates the substantial equivalency of the Life Spine Foot and Ankle Plating System.