(109 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of bone plates, screws, and cables. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, described as an internal fixation system for bone fractures, osteotomies, and arthrodesis, directly treats and manages a medical condition (bone fractures and related issues), fitting the definition of a therapeutic device.
No
The device is an orthopedic plating system for internal fixation of bone fractures, osteotomies, and arthrodesis, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the Pangea Utility Plating System and Pangea Platform consist of physical components such as plates, screws, and cable plugs made from materials like Ti6Al4V-ELI and CoCr. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "internal fixation of bone fractures, osteotomies, and arthrodesis." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as plating systems, screws, and cable plugs made of materials like Ti6Al4V-ELI and CoCr. These are implants designed to be surgically placed within the body to stabilize bone.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of the Pangea Utility Plating System and Pangea Platform does not involve any of these activities.
The device is a surgical implant used for orthopedic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Utility Plating System and the Pangea Platform. This submission encompasses multiple systems (Pangea Utility Plating System and Pangea Platform) that have similar intended use and/or will be used together during the surgical procedure. The Pangea Utility Plating System consists of mini-, small-, and large-fragment plates manufactured from Ti6Al4V-ELI per ASTM F136. The plates range in length from 26 mm to 486 mm. The Pangea Platform consists of screws and cable plugs. The screws are offered as locking or non-locking variants. The locking screws are manufactured from CoCr and are available as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm), Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20 mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking screw is manufactured from Titanium alloy (Ti6Al4V-ELI per ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm). The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per ASTM F136), and the T15 and T20 cable plugs are available for the 3.5mm locking mechanism. The Cancellous screws are available as Ø4.0 mm fully and partially threaded (L10-100 mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm thread (L45 -150 mm) and fully threaded (L20-150 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone fractures
Indicated Patient Age Range
Children (2-12 years) and adolescents (12 - 21 years)
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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
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 PRAStaff@fda.hhs.gov
"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 PRAStaff@fda.hhs.gov
"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
Pangea ™ Platform |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Regulation Description: | 21 CFR 888.3030: Single/Multiple component metallic bone
fixation appliances and accessories
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
Bohnackerweg 1
2545 Selzach / Switzerland |
| Contact Person: | Danese Joiner-Fox
Associate Manager Regulatory Affairs
325 Corporate Drive
Mahwah, NJ 07430
Phone: (475) 333-4452 |
| Date Prepared: | 05/01/2023 |
| Primary Predicate: | PeriPRO Femur and Variable Angle Fixation (K222381) |
| Additional Predicates: | 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) |
| Description | This Traditional 510(k) submission is being supplied to the
U.S. FDA to gain clearance to market the Pangea Utility
Plating System and the Pangea Platform. This submission
encompasses multiple systems (Pangea Utility Plating System
and Pangea Platform) that have similar intended use and/or
will be used together during the surgical procedure. The
Pangea Utility Plating System consists of mini-, small-, and
large-fragment plates manufactured from Ti6Al4V-ELI per
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.
The screws are offered as locking or non-locking variants. The
locking screws are manufactured from CoCr and are available
as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm),
Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20
mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking
screw is manufactured from Titanium alloy (Ti6Al4V-ELI per
ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm).
The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per
ASTM F136), and the T15 and T20 cable plugs are available
for the 3.5mm locking mechanism. The Cancellous screws are
available as Ø4.0 mm fully and partially threaded (L10-100
mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm
thread (L45 -150 mm) and fully threaded (L20-150 mm). |
| | Pangea Utility Plating System
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. |
| | Pangea Platform
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) |
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: