510(k) · Cleared
ClearedProximal Humerus Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 14, 2024 as substantially equivalent to K143697 (Biomet Manufacturing, 2015) and 1 other predicate after a 90-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Nov 14, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K954385 (1996). 105 ancestors in all, the oldest K875156 (1988). No later device cites it as a predicate yet.
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 2 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 1 generation backK181091 AxSOS 3 TiStryker GmbH · 2018
- This deviceK242436 Proximal Humerus Fixation SystemSkeletal Dynamics, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 15 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 14 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 13 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 12 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 11 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 10 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 9 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 8 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 4 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 3 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 2 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 1 generation backK181091 AxSOS 3 TiStryker GmbH · 2018
- This deviceK242436 Proximal Humerus Fixation SystemSkeletal Dynamics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −16 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −15 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −14 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −13 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −12 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −11 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −10 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −9 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −8 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −4 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −3 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −2 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −1 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| 0 (this device) | K242436 | Proximal Humerus Fixation System | Skeletal Dynamics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K143697 | Biomet Proximal Humerus Plating SystemSummary page 5…, 21 CFR §888.3040 Regulatory Class: Class II Product Code: HRS (Primary), HWC Primary Predicate Device • Biomet A.L.P.S Proximal Humerus Fixation System (ALPS PHP) (K143697) Additional Predicate • 4.0 mm screws of the Stryker AxSOS 3 Ti System (K181091) Reference Devices • Distal Humerus Plating… | 2015 |
| * | K181091 | AxSOS 3 TiSummary page 5…mary Predicate Device • Biomet A.L.P.S Proximal Humerus Fixation System (ALPS PHP) (K143697) Additional Predicate • 4.0 mm screws of the Stryker AxSOS 3 Ti System (K181091) Reference Devices • Distal Humerus Plating System (K213895) Device Description The Skeletal Dynamics Proximal Humerus Fixati… | 2018 |
| † | K213895 | Distal Humerus Plating System | 2022 |
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 6 companies; a new generation was cleared every 10 months on median.
- 21 of the 105 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143697.
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?
The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242436: Proximal Humerus Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242436
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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