PARALOCK PLATING SYSTEM / TUFFNEK SCREW

K140397 · Paragon 28 · HRS · Apr 17, 2014 · Orthopedic

Device Facts

• Record ID: K140397
• Device Name: PARALOCK PLATING SYSTEM / TUFFNEK SCREW
• Applicant: Paragon 28
• Product Code: HRS · Orthopedic
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction 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. In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

Device Story

ParaLock Plating System and TUFFNEK screws are metallic bone fixation implants for lower extremity surgery. System includes plates in various shapes (mini/standard) and screws (locking/non-locking) with size-matched washers. Implants are used by orthopedic surgeons in clinical settings to stabilize fractures, osteotomies, or perform joint fusions. Device provides mechanical support to bone segments during healing; surgeon selects appropriate plate/screw configuration based on anatomical requirements. Benefits include structural stabilization of small bones in feet/ankles, facilitating bone reconstruction and fracture repair.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic bending tests per ASTM F382 for plates and torsion, insertion/removal, and pullout tests per ASTM F543 for screws. No clinical data provided.

Technological Characteristics

Implants manufactured from medical grade titanium (ASTM F67) and titanium alloy (ASTM F136). System consists of plates and screws in various shapes and sizes. Mechanical performance validated via ASTM F382 and ASTM F543 standards. No software or electronic components.

Indications for Use

Indicated for stabilization and fixation of fractures, osteotomies, intra/extra articular fractures, joint depression, multi-fragmentary fractures, revision procedures, joint fusion, and reconstruction of small bones of toes, feet, and ankles (distal tibia, talus, calcaneus) in adult and pediatric patients. Non-locking screws/washers indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fixation.

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

• Normed Extremity Titanium Hand and Small Fragment System (K011118)
• Normed Titanium Calcaneus Plating with Locking Screw System (K022324)
• Normed Titanium Osteotomy Plating System (K022325)
• Wright Medical ORTHOLOC 3Di Hallux System (K120359)
• Wright Medical ORTHOLOC 3Di Ankle Fusion Plating System (K121425)
• Wright Medical ORTHOLOC 3Di Midfoot/Flatfoot System (K121651)
• CHARLOTTE Snap-Off Screw (K043583, K050819)
• M3-X Extremity Fixation (K924018)
• Arthrex Titanium Opening Wedge Osteotomy System (K032187)
• Arthrex Small Fragment Plates and Screws (K040907)
• Arthrex Low Profile Plate and Screw System (K052614)
• Arthrex Low Profile Screws (K103705)
• Arthrex Distal Extremity Plate System (K111253)
• Stryker Foot Plating System (K063875)
• Mini MaxLock Extreme Plating System (K101962, K120157, K121437)
• OsteoMed Foot Plating System (K091614)

Submission Summary (Full Text)

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K140397 page 1 of 2

# 510(k) Summary

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| Date: | 14 February 2014 |
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| Sponsor: | Paragon 28, Inc. |
| | 4B Inverness Ct. E., STE 280 |
| | Englewood, Colorado 80112 |
| | Phone: [phone] |
| | Facsimile: [phone] |
| Contact Person: | Frank S. Bono, Chief Technology Officer |
| Trade Names: | ParaLock Plating System ^™ |
| Device Classification | Class II |
| Regulations, Product<br>Codes, Classification<br>& Common Names: | 888.3030, HRS, Single/multiple component metallic bone fixation appliances and accessories, bone plate system |
| | 888.3040, HWC, Smooth or threaded metallic bone fixation fastener, bone screw |
| | 888.3030, HTN, Single/multiple component metallic bone fixation appliances and accessories, washer |
| Device Description: | The ParaLock Plating System ^™ and TUFFNEK ^™ screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK ^™ screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK ^™ screws when the latter are used for fixation without the plates. |
| Intended Use: | The ParaLock Bone Plates and TUFFNEK ^™ Bone Screws of the ParaLock Plating System ^™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction 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. In addition, the TUFFNEK ^™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. |
| Materials: | The ParaLock and TUFFNEK ^™ implants are manufactured from medical grade titanium (per ASTM F67) and titanium alloy (per ASTM F136). |
| Predicate Devices: | • The Normed Extremity Titanium Hand and Small Fragment System, the Normed Titanium Calcaneus Plating with Locking Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K011118, K022324 and K022325, respectively) |
| | • The Wright Medical ORTHOLOC ^™ 3Di Hallux System, The Wright Medical ORTHOLOC ^™ 3Di Ankle Fusion Plating System and The Wright Medical ORTHOLOC ^™ 3Di Midfoot/Flatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) |
| | • CHARLOTTE ^™ Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) |
| | • M3-X Extremity Fixation (OsteoMed Corp., K924018) |
| | • The Arthrex Titanium Opening Wedge Osteotomy System, the Arthrex Small Fragment Plates and Screws, Low Profile Plate and Screw System, the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K032187, K040907, K052614, K103705 and K111253, respectively) |

APR 1 7 2014

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| | • The Stryker® Foot Plating System (Howmedica Osteonics - K063875)<br>• The Mini MaxLock Extreme® Plating System (OrthoHelix Surgical Designs<br>Inc. - K101962, K120157 & K121437)<br>• OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Mechanical testing of the worst case ParaLock Plates included static and<br>dynamic bending performed according to ASTM F382. Mechanical testing of<br>the worst case TUFFNEK™ screws included torsion, insertion/removal and<br>pullout performed according to ASTM F543. The mechanical test results and<br>theoretical comparisons demonstrated that the mechanical performance of the<br>ParaLock Plating System™ and TUFFNEK™ screws is substantially<br>equivalent to the predicate devices. |
| Technological<br>Characteristics: | The ParaLock Plating System™ and TUFFNEK™ screws possess the same<br>technological characteristics as one or more of the predicate devices. These<br>include: |
| | • performance (as described above),<br>• basic design (screws and plates in various shapes),<br>• material (titanium and/or titanium alloys) and<br>• sizes (dimensions are comparable to those offered by the predicate<br>systems). |
| | Therefore the fundamental scientific technology of the ParaLock Plating<br>System™ is the same as previously cleared devices. |
| Conclusion: | The ParaLock Plating System™ and TUFFNEK™ screws possess the same<br>intended use and technological characteristics as the predicate devices.<br>Therefore the ParaLock Plating System™ and TUFFNEK™ screws are<br>substantially equivalent for its intended use. |

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2014

Paragon 28, Inc. % Ms. Karen E. Warden, Ph.D. Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566

Re: K140397

Trade/Device Name: ParaLock 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, HTN Dated: March 3, 2014 Received: March 4, 2014

Dear Dr. Warden:

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

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### Page 2 - Dr. Karen E. Warden

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely vours.

## Lori A. Wiggins

- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K140397 page 1 of 1

### Indications for Use Statement

K140397 510(k) Number:

Device Name: ParaLock Plating System™

Indications for Use:

The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction 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.

In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

> Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices