510(k) · Cleared
ClearedPangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HRS Plate, Fixation, Bone
Cleared on Oct 6, 2024 as substantially equivalent to K231257 (Stryker GmbH, 2023) and 1 other predicate after a 51-day review. Its family tree reaches back 20 generations to 1996.
- Decided
- Oct 6, 2024
- Review
- 51 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K954385 (1996). 351 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations between
- 3 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 2 generations backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- 1 generation backK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
- This deviceK242445 Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating…Stryker GmbH · 2024
Show all 20 generations
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 19 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 18 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 17 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 16 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 15 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 14 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 13 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 12 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 11 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 10 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 9 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 7 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 6 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 5 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 4 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 3 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 2 generations backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- 1 generation backK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
- This deviceK242445 Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating…Stryker GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −19 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −18 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −17 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −16 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −15 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −14 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −13 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −12 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −11 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −10 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −9 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −7 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −6 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −5 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −4 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| −2 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| −1 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | — |
| 0 (this device) | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System… | Stryker GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 24 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 17 | 0 |
| 2001 | 25 | 0 |
| 2002 | 19 | 0 |
| 2003 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 20 | 0 |
| 2006 | 28 | 0 |
| 2007 | 10 | 0 |
| 2008 | 16 | 0 |
| 2009 | 11 | 0 |
| 2010 | 13 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231257 | Pangea Utility Plating System, Pangea PlatformSummary page 6…[email protected] Date Prepared: August 16, 2024 Predicate Device: Pangea Platform (K231257), Pangea Femur Plating System, Pangea Humerus Plating System, Pangea Tibia Plating Sy… | 2023 |
| * | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Summary page 6…Pangea Platform (K231257), Pangea Femur Plating System, Pangea Humerus Plating System, Pangea Tibia Plating System (K231262) Device Description: This traditional 510(k) submission is being supplied to the U.S. FDA to gain… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 60 of the 351 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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) and adolescents (12 - 21 years) for the internal fixation and…
Read the full statement (223 words)
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) 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 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 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 and stabilization 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 and stabilization 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026