The Locking Pediatric Osteotomy Plate (LolliPOP) System

K170704 · Pega Medical, Inc. · KTT · Sep 8, 2017 · Orthopedic

Device Facts

• Record ID: K170704
• Device Name: The Locking Pediatric Osteotomy Plate (LolliPOP) System
• Applicant: Pega Medical, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Sep 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatic (ages 2 to 21 years old) population. Indications for use include the following: - . Inter and subtrochanteric valgus osteotomies - 0 Inter and subtrochanteric varus osteotomies - Inter and subtrochanteric derotation osteotomies - Inter and subtrochanteric flexion and extension osteotomies ● - Inter and subtrochanteric fractures

Device Story

Modular hip blade-plate system for pediatric proximal femoral osteotomies and fractures; provides stable bone fixation. System includes plates, connectors, locking cortical screws, and polyaxial compression screws. Used by surgeons in clinical settings to treat hip deformities like Coxa Valga/Vara. Implants stabilize bone segments post-osteotomy, facilitating healing and deformity correction. Surgeon selects appropriate size (infant, child, adolescent, adolescent HD) based on patient anatomy.

Clinical Evidence

No clinical testing provided. Evidence consists of bench testing (single cycle/fatigue compression, screw performance, plate bending strength) and a systematic literature review of predicate systems to address clinical hazards.

Technological Characteristics

Modular hip blade-plate system; 316L Stainless Steel (ASTM F138). Components: plates, connectors, locking cortical screws, polyaxial compression screws. Four sizes: infant, child, adolescent, adolescent HD. Mechanical fixation via screws.

Indications for Use

Indicated for pediatric patients (ages 2-21) requiring stable fixation for proximal femoral osteotomies (valgus, varus, derotation, flexion, extension) or inter/subtrochanteric fractures.

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

• Cannulated Pediatric Osteotomy (CAPOS) system (K914546)
• TC-100 plating and screw system (K033669)
• Locking Cannulated Blade (LCB) plate system (K110959)
• Modular Blade Plate System (K080109)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

September 8, 2017

Pega Medical Inc. Mr. Ariel Dujovne President 1111 Highwav Chomedev Laval. Quebec. H7W 5J8 Canada

Re: K170704

Trade/Device Name: The Locking Pediatric Osteotomy Plate (LolliPOP) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: July 24, 2017 Received: July 26, 2017

Dear Mr. Dujovne:

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

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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 (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) at its toll-free 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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) K170704

Device Name

The Locking Pediatric Osteotomy Plate (LolliPOP) System

Indications for Use (Describe)

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following:

*Inter and subtrochanteric valgus osteotomies

*Inter and subtrochanteric varus osteotomies

*Inter and subtrochanteric derotation osteotomies

*Inter and subtrochanteric flexion and extension osteotomies,

*Inter and subtrochanteric fractures.

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 OF SAFETY AND EFFECTIVENESS

| Applicant: | Pega Medical Inc.<br>1111 Highway Chomedey<br>Laval, Quebec, Canada, H7W 5J8<br>Phone: [phone] |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Ariel R. Dujovne |
| Proprietary Name: | The Locking Pediatric Osteotomy Plate (LolliPOP)<br>System |
| Common Name: | Blade plate system |
| Regulation Number: | 21 CFR 888.3030<br>Single/multiple component metallic bone fixation<br>appliances and accessories. |
| Device Classification: | Class II |
| Device Classification Name: | Appliance, Fixation, Nail/Blade/plate Combination,<br>Multiple Components |
| Device Product Code: | KTT |
| Establishment Registration Number: | 9048931 |

# Intended Use:

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatic (ages 2 to 21 years old) population. Indications for use include the following:

- . Inter and subtrochanteric valgus osteotomies
- 0 Inter and subtrochanteric varus osteotomies
- Inter and subtrochanteric derotation osteotomies
- Inter and subtrochanteric flexion and extension osteotomies ●
- Inter and subtrochanteric fractures

#### Description:

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension, of proximal femoral osteotomies (PFO) and fractures in the pediatic population. PFOs are widely performed reconstructive surgeries in children with hip deformities, such as Coxa Valga, Coxa Vara and other congenital deformities. The implants are made of medical grade 316L Stainless Steel (ASTM F138) and are offered in four sizes: infant, child, adolescent and adolescent HD. The system is comprised of a set of plates, connectors, locking cortical screws, polyaxial compressions screws, and all the instrumentation required for implantation and retrieval of the device.

#### Basis for substantial equivalence:

The Locking Pediatric Osteotomy Plate (LolliPOP) System is claimed to be substantially equivalent in design, indicated use and function to the following predicate devices:

| Labeling Name | marketed by | 510(k) number |
|----------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------|
| Cannulated Pediatric Osteotomy (CAPOS) system<br>(Primary predicate) | Synthes USA LLC | Angled Blade Plate<br>K914546 |
| TC-100 plating and screw system | Smith & Nephew, Inc. Orthopaedic Division | Locking Bone Plate System<br>K033669<br>(previously K993106) |
| Locking Cannulated Blade (LCB) plate system | OrthoPediatrics, Corp. | Blade Plate System<br>K110959 |
| Modular Blade Plate System | Synthes USA LLC | Modular Blade Plate System<br>K080109 |

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# Summary of Technologies:

The technological characteristics of the Locking Pediatric Osteotomy Plate (LolliPOP) System are the same or similar to the ones of the predicate devices for the described intended uses. Furthermore, the Locking Pediatric Osteotomy Plate (LolliPOP) System and all predicate systems use screws as the primary fixation method. Finally, modularity of the LolliPOP System is equivalent to that of the Modular Blade Plate system.

# Non-clinical Performance Data:

Verification calculations were completed to evaluate resistance of the Locking Pediatric Osteotomy Plate System in comparison to the predicate systems. The mechanical properties of all the blade, plate and screw components of the system were analysed in comparison to the predicate systems. Furthermore, the bench testing of the Locking Pediatric Osteotomy Plate in static and fatigue confirmed the validity of these calculations.

The following non-clinical Performance testing were completed:

- Single cycle and fatigue compression bend testing on the construct
- Screw performance (torsional strength, axial pullout, driving torque)
- Bending strength of the plate

Results of the bench testing on the Locking Pediatric Osteotomy Plate System and predicate Synthes CAPOS System demonstrate that the systems perform equivalently.

Finally, a systematic search of the scientific literature was carried out and a Clinical Evidence Review report was issued. This report intended to identify and analyze the published peer-reviewed scientific literature regarding the intended uses, and more specifically of the two predicate systems, in order to establish the safety and effectiveness of the subject system by addressing the clinical hazards identified in the device Risk Analysis.

As per the findings of the bench testing and the scientific literature review, the data supports the use of this product as safe and effective for its intended use; the anticipated benefits of such a system clearly outweigh the possible residual risks.

#### Clinical Performance Data:

No clinical testing is provided as a basis for substantial equivalence.

# Conclusion:

Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, the Locking Pediatric Osteotomy Plate (LolliPOP) System has been established as substantially equivalent to the previously cleared predicate devices. Furthermore, mechanical evaluation results demonstrate that the proposed system is substantially equivalent to the predicate devices.