510(k) Report

510(k) · Cleared

Cleared

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System

K231262510(k) TraditionalCleared Aug 18, 2023109-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker GmbH · HRS Plate, Fixation, Bone

Cleared on Aug 18, 2023 as substantially equivalent to K200398 (Stryker GmbH, 2020) and 7 other predicates after a 109-day review. Its family tree reaches back 19 generations to 1996. 4 later devices descend from it.

Decided
Aug 18, 2023
Review
109 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 19 generations to K954385 (1996). 263 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 3 other ancestors2013: 3 other ancestors2008: 12 other ancestors2006: 25 other ancestors2019: 2 other ancestors2017: 4 other ancestors2014: 5 other ancestors2012: 3 other ancestors2005: 17 other ancestors2002: 18 other ancestors2001: 19 other ancestors1997: 3 other ancestors2016: 1 other ancestor2010: 8 other ancestors2009: 10 other ancestors2007: 8 other ancestors2004: 8 other ancestors1996: 16 other ancestors2011: 5 other ancestors2003: 8 other ancestors2000: 14 other ancestors1999: 9 other ancestors1998: 9 other ancestors1995: 9 other ancestors1994: 8 other ancestors1993: 2 other ancestors1988: 1 other ancestor1990: 1 other ancestor1992: 4 other ancestors1991: 1 other ancestor1989: 4 other ancestors1987: 1 other ancestor1981: 1 other ancestor1979: 2 other ancestors2025: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998×2: 2 generations cleared close together, K030448 (2003), K032442 (2003) K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalled×2: 2 generations cleared close together, K100618 (2010), K102156 (2010) K113048 · Maxlock Extreme System · Orthohelix Surgical Designs, Inc. · 2012×2: 2 generations cleared close together, K122005 (2012), K123203 (2012) K132591 · Maxlock Extreme System · Orthohelix Surgical Designs, Inc. · 2013K153379 · AxSOS 3Ti · Stryker GmbH · 2016K162439 · AxSOS 3 Ti; Stryker Plating System · Stryker GmbH · 2017K172350 · AxSOS 3 Ti · Stryker GmbH · 2017K181091 · AxSOS 3 Ti · Stryker GmbH · 2018K200398 · AxSOS 3 AF System and AxSOS 3 Ti System · Stryker GmbH · 2020K222381 · PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System · Stryker GmbH · 202319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 15 other ancestors3 generations back: 25 other ancestors4 generations back: 59 other ancestors5 generations back: 53 other ancestors6 generations back: 39 other ancestors7 generations back: 14 other ancestors8 generations back: 10 other ancestors9 generations back: 13 other ancestors10 generations back: 9 other ancestors11 generations back: 2 other ancestors12 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant K222381 · PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System · Stryker GmbH · 2023K200398 · AxSOS 3 AF System and AxSOS 3 Ti System · Stryker GmbH · 2020K181091 · AxSOS 3 Ti · Stryker GmbH · 2018K172350 · AxSOS 3 Ti · Stryker GmbH · 2017K162439 · AxSOS 3 Ti; Stryker Plating System · Stryker GmbH · 2017K153379 · AxSOS 3Ti · Stryker GmbH · 2016K132591 · Maxlock Extreme System · Orthohelix Surgical Designs, Inc. · 2013K123203 · Maxlock Extreme System Model MXL · Orthohelix Surgical Designs, Inc. · 2012K122005 · Maxlock Extreme System · Orthohelix Surgical Designs, Inc. · 2012K113048 · Maxlock Extreme System · Orthohelix Surgical Designs, Inc. · 2012K102156 · Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws · Orthohelix Surgical Designs, Inc. · 2010 · recalledK100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 2010K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996−15−10−50
  1. Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 15 generations between
  3. 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
  4. 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  5. 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
  6. This deviceK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
  7. Descendant · cites it directly · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
  8. Descendant · cites it directly · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
  9. Descendant · 2 generations on · 0 of its ownK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
  10. Descendant · cites it directly · 0 of its ownK242445 Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating…Stryker GmbH · 2024
Show all 19 generations
  1. Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 18 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 17 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 16 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 15 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 14 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. 13 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  8. 12 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  9. 11 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
  10. 10 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
  11. 9 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
  12. 8 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
  13. 7 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
  14. 6 generations backK153379 AxSOS 3TiStryker GmbH · 2016
  15. 5 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
  16. 4 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
  17. 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
  18. 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  19. 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
  20. This deviceK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023

Most influential descendants

Showing 4 of 4 · See all
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · cites it directly2descendants
  • K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · cites it directly1descendant
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 2 generations on0descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−19K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−18K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−17K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−16K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−15K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−14K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
−13K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
−12K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
−11K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101
−10K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.2012—
−9K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.2012—
−8K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.2012—
−7K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.2013—
−6K153379AxSOS 3TiStryker GmbH2016—
−5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH2017—
−4K172350AxSOS 3 TiStryker GmbH2017—
−3K181091AxSOS 3 TiStryker GmbH2018—
−2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
−1K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—
0 (this device)K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia…Stryker GmbH2023—
+1K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025—
+1K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026—
+2K261481Pangea Femur Reconstruction SystemStryker GmbH2026—
+1K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System…Stryker GmbH2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198110
198710
198810
198940
199010
199110
199240
199320
199480
199590
1996160
199730
199890
199990
2000140
2001190
2002180
200380
200480
2005170
2006250
200780
2008120
2009100
201080
201150
201230
201330
201450
201530
201610
201740
201920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
202620
FIG. 1 — Lineage of K231262, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K200398AxSOS 3 AF System and AxSOS 3 Ti System
Summary page 7
…Phone: (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…
Stryker GmbH2020—
*K181091AxSOS 3 Ti
Summary page 7
…Phone: (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…
Stryker GmbH2018—
*K153379AxSOS 3Ti
Summary page 7
…Phone: (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…
Stryker GmbH2016—
*K123964Axsos 3 TI Locking Plate System
Summary page 7
…one: (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…
Stryker Trauma AG2013—
*K060798Stryker Plating System
Summary page 7
…1091/ K153379/ K123964) Additional Predicate: SPS Small Fragment Set The Stryker® Plating System (K060798) VariAx Fibula (K081284) VariAx 2 One…
Howmedica Osteonics Corp.2006—
*K081284Variax Distal Fibula Plate
Summary page 7
…SPS Small Fragment Set The Stryker® Plating System (K060798) VariAx Fibula (K081284) VariAx 2 One-Third Tubular Plating System (K151879)…
Howmedica Osteonics Corp.2008—
*K151879VariAx 2 One-Third Tubular Plating System
Summary page 7
…(K060798) VariAx Fibula (K081284) VariAx 2 One-Third Tubular Plating System (K151879) PeriPRO Femur and Variable Angle Fixation (K222381) Description…
Stryker GmbH2015—
*K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
Summary page 7
…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.…
Stryker GmbH2023—

Also cleared against K200398: 2 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261
K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240

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.
  • 49 of the 263 ancestors have a recall of any class.
  • Of its descendants, K250163 (Stryker GmbH, 2025) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K200398.

How does its category compare?

All HRS devices

HRS 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

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

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 Fibula Plating System: The Pangea Fibula Plating System is indicated for the internal fixation and…

Read the full statement (180 words)

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 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 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.

Also cleared against K200398

2 other devices cite the same predicate.

  • K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023

More from Stryker GmbH

55 FDA decisions under this applicant name. See the company

  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253202Hoffmann LRF SystemStryker GmbH · 2025
  • K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K231262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231262

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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