510(k) · Cleared
ClearedPangea Femur Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 29, 2026 as substantially equivalent to K253640 (Stryker GmbH, 2026) and 2 other predicates after a 55-day review. Its family tree reaches back 22 generations to 1996.
- Decided
- Jun 29, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K954385 (1996). 344 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 22 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 18 generations between
- 3 generations backK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- 2 generations backK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- 1 generation backK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- This deviceK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
Show all 22 generations
- Root · 22 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 21 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 20 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 19 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 18 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 17 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 16 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 15 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 14 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 13 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 12 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 11 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 10 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 9 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 8 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 7 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 6 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 5 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 4 generations backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- 3 generations backK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- 2 generations backK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- 1 generation backK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- This deviceK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −21 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −20 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −19 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −18 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −17 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −16 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −15 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −14 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −13 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −12 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −11 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −10 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −9 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −8 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −7 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −6 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −5 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| −4 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| −3 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 2023 | — |
| −2 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| −1 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| 0 (this device) | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 21 | 0 |
| 1997 | 9 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 16 | 0 |
| 2001 | 26 | 0 |
| 2002 | 22 | 0 |
| 2003 | 14 | 0 |
| 2004 | 14 | 0 |
| 2005 | 21 | 0 |
| 2006 | 26 | 0 |
| 2007 | 10 | 0 |
| 2008 | 14 | 0 |
| 2009 | 11 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemSummary page 5…[email protected] Date Prepared: May 5, 2026 Predicate Device: Pangea Femur Reconstruction System (K253640, primary predicate) Dall-Miles Cable System (K202016)… | 2026 |
| * | K202016 | Dall-Miles® Cable SystemSummary page 5…026 Predicate Device: Pangea Femur Reconstruction System (K253640, primary predicate) Dall-Miles Cable System (K202016) AxSOS 3 Ti System (K222381) Device Description: The Pangea Femur Recons… | 2020 |
| * | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemSummary page 5…tion System (K253640, primary predicate) Dall-Miles Cable System (K202016) AxSOS 3 Ti System (K222381) Device Description: The Pangea Femur Reconstruction System, previously cleared in… | 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 30 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 86 of the 344 ancestors have a recall of any class.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Pangea Femur Reconstruction 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.
Additionally, the Trochanter Plates and Trochanter Attachment Plate are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy.
When used with the T2 Alpha Femur Retrograde Nailing System, The Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261481: Pangea Femur Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261481
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026