510(k) · Cleared
ClearedPangea Utility Plating System, Pangea Platform
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 Aug 18, 2023 as substantially equivalent to K222381 (Stryker GmbH, 2023) and 6 other predicates after a 109-day review. Its family tree reaches back 19 generations to 1996. 1 later device descends from it.
- Decided
- Aug 18, 2023
- Review
- 109 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 19 generations to K954385 (1996). 343 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations between
- 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- This deviceK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
- Descendant · cites it directly · 0 of its ownK242445 Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating…Stryker GmbH · 2024
Show all 19 generations
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 18 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 17 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 16 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 15 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 14 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 13 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 12 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 11 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 10 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 9 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 6 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 5 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 4 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- This deviceK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −18 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −17 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −16 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −15 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −14 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −13 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −12 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −11 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −10 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −9 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −6 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −5 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −4 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −3 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −2 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| −1 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| 0 (this device) | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | — |
| +1 | 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 | 24 | 0 |
| 2002 | 19 | 0 |
| 2003 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 19 | 0 |
| 2006 | 26 | 0 |
| 2007 | 10 | 0 |
| 2008 | 16 | 0 |
| 2009 | 11 | 0 |
| 2010 | 13 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (7)
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 |
|---|---|---|---|
| * | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemSummary page 5…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 S… | 2023 |
| * | K180500 | VariAx 2 SystemSummary page 5…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)… | 2018 |
| * | K191412 | VariAx 2 System, VariAx 2 Mini Fragment SystemSummary page 5…81) Additional Predicates: VariAx 2 System (K180500) VariAx 2 System, VariAx 2 Mini Fragment System (K191412) VariAx 2 One-Third Tubular Plating System (K151879)… | 2019 |
| * | K151879 | VariAx 2 One-Third Tubular Plating SystemSummary page 5…VariAx 2 System, VariAx 2 Mini Fragment System (K191412) VariAx 2 One-Third Tubular Plating System (K151879) Osteo BOS System (K972323) AxSOS 3 Ti… | 2015 |
| * | K972323 | Osteo Bos SystemSummary page 5…(K191412) VariAx 2 One-Third Tubular Plating System (K151879) Osteo BOS System (K972323) AxSOS 3 Ti System (K200398) Dall-Miles… | 1997 |
| * | K200398 | AxSOS 3 AF System and AxSOS 3 Ti SystemSummary page 5…Tubular Plating System (K151879) Osteo BOS System (K972323) AxSOS 3 Ti System (K200398) Dall-Miles Cable System (K202016) Description Thi… | 2020 |
| * | K202016 | Dall-Miles® Cable SystemSummary page 5…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… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea… | 2024 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 59 of the 343 ancestors have a recall of any class.
- Of its descendants, K242445 (Stryker GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K222381.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
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…
Read the full statement (176 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231257: Pangea Utility Plating System, Pangea Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231257
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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