(109 days)
Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation of femur bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions and deformities
- · Periprosthetic fractures
Pangea Fibula Plating System:
The Pangea Fibula Plating System is indicated for the internal fixation of fibula bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic fractures
Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation of tibia bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic fractures
Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation of humerus bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities - · Periprosthetic fractures
This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System. This submission encompasses multiple systems that have similar intended use. All plates are manufactured from Ti6Al4V ELI (ASTM F136), are anatomically pre-contoured. and are available in different sizes and left/right versions. The plates are provided sterile or non-sterile and range in length from 68 mm to 441 mm. The plates allow for the use of locking and non-locking screws and are used with cable plugs and washers.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is an FDA 510(k) clearance letter for the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System.
The letter indicates that clinical testing was not required for this submission, and therefore, there are no details regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The document discusses non-clinical testing performed to support substantial equivalence, including:
- Dynamic construct testing
- Magnetic Resonance (MR) compatibility assessments:
- Magnetically Induced Displacement per ASTM F2052
- Magnetically Induced Torque per ASTM F2213
- Image Artifacts per ASTM F2119
- RF Heating per ASTM F2182
These tests are typically performed to ensure the physical and mechanical properties of the device and its compatibility with imaging environments, rather than evaluating performance for diagnostic or clinical decision-making.
Therefore, I cannot populate the requested table and information based on the provided text.
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August 18, 2023
Image /page/0/Picture/1 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.
Stryker GmbH Danese Joiner-Fox Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah. New Jersey 07430
Re: K231262
Trade/Device Name: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus 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: May 1, 2023 Received: May 1, 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.
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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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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510(k) Number (if known) K231262
Device Name Pangea Femur Plating System
Indications for Use (Describe)
Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation of femur bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions and deformities
- · Periprosthetic 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)
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 PRAStaff(@fda.hhs.gov
{3}------------------------------------------------
510(k) Number (if known)
Device Name Pangea Fibula Plating System
Indications for Use (Describe)
Pangea Fibula Plating System:
The Pangea Fibula Plating System is indicated for the internal fixation of fibula bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic 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)
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 PRAStaff(@fda.hhs.gov
{4}------------------------------------------------
510(k) Number (if known)
Device Name Pangea Tibia Plating System
Indications for Use (Describe)
Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation of tibia bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions, malunions, and deformities
- · Periprosthetic 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)
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 PRAStaff(@fda.hhs.gov
{5}------------------------------------------------
510(k) Number (if known)
Device Name Pangea Humerus Plating System
Indications for Use (Describe)
Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation of humerus bone fractures and osteotomies in normal and osteopenic bone, including:
-
· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities -
· Periprosthetic 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)
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 PRAStaff(@fda.hhs.gov
{6}------------------------------------------------
Stryker GMBH Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Traditional 510(k) Premarket Notification Plating System
K231262 510(k) Summary
| Proprietary Name: | Pangea™ Femur Plating SystemPangea™ Fibula Plating SystemPangea™ Tibia Plating SystemPangea™ Humerus Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Description: | 21 CFR 888.3030: Single/Multiple component metallic bonefixation appliances and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS, HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GMBHBohnackerweg l2545 Selzach / Switzerland |
| Contact Person: | Danese Joiner-FoxAssociate Manager Regulatory Affairs325 Corporate DriveMahwah, NJ 07430Phone: (475) 333-4452 |
| Date Prepared: | 05/01/2023 |
| Primary Predicate: | AxSOS 3 Ti System (K200398/K181091/ K153379/ K123964) |
| Additional Predicate: | SPS Small Fragment Set The Stryker® Plating System(K060798)VariAx Fibula (K081284)VariAx 2 One-Third Tubular Plating System (K151879)PeriPRO Femur and Variable Angle Fixation (K222381) |
| Description | This traditional 510(k) submission is being supplied to the U.S.FDA to gain clearance to market the Pangea Femur PlatingSystem, Pangea Fibula Plating System, Pangea Tibia PlatingSystem, and Pangea Humerus Plating System. This submissionencompasses multiple systems that have similar intended use. |
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Stryker GMBH Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System Traditional 510(k) Premarket Notification
All plates are manufactured from Ti6Al4V ELI (ASTM F136), are anatomically pre-contoured. and are available in different sizes and left/right versions. The plates are provided sterile or non-sterile and range in length from 68 mm to 441 mm. The plates allow for the use of locking and non-locking screws and are used with cable plugs and washers.
Indications for Use
Pangea Femur Plating System
The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:
· Diaphyseal, metaphyseal, epiphyseal, extra- and intraarticular fractures
- Non-unions, malunions, and deformities
- · Periprosthetic fractures
Pangea Fibula Plating System
The Pangea Fibula Plating System is indicated for the internal fixation and stabilization of fibula bone fractures and osteotomies in normal and osteopenic bone, including:
· Diaphyseal, metaphyseal, epiphyseal, extra- and intraarticular fractures
- Non-unions, malunions, and deformities
- · Periprosthetic fractures
Pangea Tibia Plating System
The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:
· Diaphyseal, metaphyseal, epiphyseal, extra- and intraarticular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
Pangea Humerus Plating System
The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intraarticular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
Summary of Technologies
{8}------------------------------------------------
Stryker GMBH Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System Traditional 510(k) Premarket Notification
A comparison of the systems demonstrated that the subject Pangea Femur Plating System. Pangea Fibula Plating System. Pangea Tibia Plating System, Pangea Humerus Plating System is substantially equivalent to the AxSOS 3 Ti (K181091/ K200398), SPS Small Fragment Set The Stryker® Plating System (K060798), VariAx 1/3 tubular (K151879), VariAx Fibula (K081284), and PeriPRO Femur and Variable Angle Fixation (K222381) in regard to intended use, material, design, and operational principles.
Non-Clinical Testing: The following non-clinical laboratory testing, and performance assessments were made in support of substantial equivalence:
-
Dynamic construct testing
Assessments performed to establish compatibility with a magnetic resonance environment: -
Magnetically Induced Displacement per ASTM F2052
-
Magnetically Induced Torque per ASTM F2213
-
Image Artifacts per ASTM F2119
Tests performed to establish compatibility with a magnetic resonance environment:
- . RF Heating per ASTM F2182
Clinical testing was not required for this submission.
The subject device Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System are substantially equivalent to the previously cleared predicate device AxSOS 3 Ti (K200398/K181091/ K153379/ K123964). Except for the modifications described in this submission, the subject devices are identical to the predicate device, 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:
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.