Pangea Utility Plating System, Pangea Platform

K231257 · Stryker GmbH · HRS · Aug 18, 2023 · Orthopedic

Device Facts

• Record ID: K231257
• Device Name: Pangea Utility Plating System, Pangea Platform
• Applicant: Stryker GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Aug 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Pangea Utility Plating System is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions, malunions, and deformities • Periprosthetic fractures The Pangea Utility Plating System is also indicated for children (2-12 years) and adolescents (12 – 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants. The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions, malunions, and deformities • Periprosthetic fractures The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 – 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

Device Story

Pangea Utility Plating System and Pangea Platform consist of metallic bone fixation plates, screws, and cable plugs; used for internal fixation of bone fractures, osteotomies, and arthrodesis. Plates are mini-, small-, and large-fragment types; screws include locking and non-locking variants. System components are implanted by surgeons in clinical settings to stabilize bone segments; provide mechanical support during healing. Output is physical stabilization of bone; healthcare providers use intraoperative imaging to verify placement. Benefits include restoration of bone alignment and stability for patient healing.

Clinical Evidence

No clinical data. Bench testing only. Testing included: worst-case construct determination, cross-sectional/bending moment comparison, screw shear/pull-out/insertion (ASTM F543), cable plug static traction, and static/dynamic cantilever bending. MR compatibility testing performed per ASTM F2052, F2213, F2182, and F2119.

Technological Characteristics

Plates and non-locking screws: Ti6Al4V-ELI (ASTM F136). Locking screws: CoCr. Plate lengths: 26mm-486mm. Screw diameters: 2.7mm-6.0mm. Mechanical fixation via plates, screws, and cable plugs. MR conditional.

Indications for Use

Indicated for internal fixation of bone fractures, osteotomies, and arthrodesis in normal/osteopenic bone (diaphyseal, metaphyseal, epiphyseal, extra/intra-articular, non-unions, malunions, deformities, periprosthetic). Indicated for children (2-12) and adolescents (12-21) for diaphysis/metaphysis fractures where growth plates are fused or not crossed by implants.

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

• PeriPRO Femur and Variable Angle Fixation (K222381)
• VariAx 2 System (K180500)
• VariAx 2 System, VariAx 2 Mini Fragment System (K191412)
• VariAx 2 One-Third Tubular Plating System (K151879)
• Osteo BOS System (K972323)
• AxSOS 3 Ti System (K200398)
• Dall-Miles Cable System (K202016)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2023

Stryker GmbH Danese Joiner-Fox Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430

Re: K231257

Trade/Device Name: Pangea Utility Plating System, Pangea Platform 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: July 21, 2023 Received: July 21, 2023

Dear Danese Joiner-Fox:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shumaya Ali-S

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K231257

Device Name Pangea Utility Plating System

#### Indications for Use (Describe)

The Pangea Utility Plating System is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

- · Diaphyseal, metaphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic fractures

The Pangea Utility Plating System is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K231257

Device Name Pangea Platform

Indications for Use (Describe)

The Pangea Platform is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic fractures

The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

### K231257 510(k) Summary

| Proprietary Name: | Pangea ™ Utility Plating System<br>Pangea ™ Platform |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Regulation Description: | 21 CFR 888.3030: Single/Multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulation Number: | 21 CFR 888.3040 (primary), 21 CFR 888.3030 |
| Product Code: | HRS, HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GMBH<br>Bohnackerweg 1<br>2545 Selzach / Switzerland |
| Contact Person: | Danese Joiner-Fox<br>Associate Manager Regulatory Affairs<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] |
| Date Prepared: | 05/01/2023 |
| Primary Predicate: | PeriPRO Femur and Variable Angle Fixation (K222381) |
| Additional Predicates: | VariAx 2 System (K180500)<br>VariAx 2 System, VariAx 2 Mini Fragment System (K191412)<br>VariAx 2 One-Third Tubular Plating System (K151879)<br>Osteo BOS System (K972323)<br>AxSOS 3 Ti System (K200398)<br>Dall-Miles Cable System (K202016) |
| Description | This Traditional 510(k) submission is being supplied to the<br>U.S. FDA to gain clearance to market the Pangea Utility<br>Plating System and the Pangea Platform. This submission<br>encompasses multiple systems (Pangea Utility Plating System<br>and Pangea Platform) that have similar intended use and/or<br>will be used together during the surgical procedure. The<br>Pangea Utility Plating System consists of mini-, small-, and<br>large-fragment plates manufactured from Ti6Al4V-ELI per<br>ASTM F136. The plates range in length from 26 mm to 486 |
| Indications for Use | |
| | mm. The Pangea Platform consists of screws and cable plugs.<br>The screws are offered as locking or non-locking variants. The<br>locking screws are manufactured from CoCr and are available<br>as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm),<br>Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20<br>mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking<br>screw is manufactured from Titanium alloy (Ti6Al4V-ELI per<br>ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm).<br>The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per<br>ASTM F136), and the T15 and T20 cable plugs are available<br>for the 3.5mm locking mechanism. The Cancellous screws are<br>available as Ø4.0 mm fully and partially threaded (L10-100<br>mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm<br>thread (L45 -150 mm) and fully threaded (L20-150 mm). |
| | Pangea Utility Plating System<br>The Pangea Utility Plating System is indicated for the internal<br>fixation and stabilization of bone fractures, osteotomies, and<br>arthrodesis in normal and osteopenic bone, including: |
| | • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-<br>articular fractures<br>• Non-unions, malunions, and deformities<br>• Periprosthetic fractures |
| | The Pangea Utility Plating System is also indicated for<br>children (2-12 years) and adolescents (12 – 21 years) for the<br>internal fixation and stabilization of bone fractures of the<br>diaphysis and metaphysis in which growth plates have fused<br>or in which growth plates will not be crossed by implants. |
| | Pangea Platform<br>The Pangea Platform is indicated for the internal fixation and<br>stabilization of bone fractures, osteotomies, and arthrodesis in<br>normal and osteopenic bone, including: |
| | • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-<br>articular fractures<br>• Non-unions, malunions, and deformities<br>• Periprosthetic fractures |
| | The Pangea Platform is also indicated for children (2-12 years) |

{5}------------------------------------------------

and adolescents (12 – 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

#### Summary of Technologies

A comparison of the systems demonstrated that the subject Pangea Utility Plating System and Pangea Platform is substantially equivalent to the PeriPRO Femur and Variable Angle Fixation (K222381) with regard to intended use, material, design, and operational principles.

{6}------------------------------------------------

#### Non-Clinical Testing:

The following non-clinical laboratory testing and performance assessments were made in support of substantial equivalence:

- Determination of Utility Plate worst-case constructs ●
- Utility Plate cross-sectional and bending moment comparison to predicate devices
- Screw Shear Off per ASTM F543
- Screw Pull Out per ASTM F543
- . . Screw Insertion per ASTM F543
- Cable Plug Static Traction
- . Static Cantilever Bending
- Dynamic Cantilever Bending
- Multiple Usage Static Cantilever Bending .

Tests performed to establish compatibility with a magnetic resonance environment:

- Magnetically Induced Displacement per ASTM F2052 ●
- Magnetically Induced Torque per ASTM F2213
- RF Heating per ASTM F2182
- Image Artifacts per ASTM F2119

Clinical testing was not required for this submission.

The subject devices Pangea Utility Plating System and Pangea Platform are substantially equivalent to the previously cleared predicate devices PeriPRO Femur and Variable Angle Fixation (K222381). Except for the modifications described in this submission the subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that:

- any differences do not raise new questions of safety and effectiveness as established with performance testing; and
• the subject devices are at least as safe and effective as the legally marketed predicate devices

Clinical Testing:

Conclusion: