510(k) · Cleared
ClearedAft Proximal Humerus Fracture Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shoulder Options, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 1, 2012 as substantially equivalent to K041860 (Synthes (Usa), 2004) and 3 other predicates after a 117-day review. Its family tree reaches back 2 generations to 1996. 20 later devices descend from it.
- Decided
- Oct 1, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K961413 (1996). 6 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 1 generation backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- This deviceK121672 Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012
- Descendant · cites it directly · 16 of its ownK133668 Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity…Shoulder Options, Inc. · 2014
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc. · 2014 · cites it directly16descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| −1 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| 0 (this device) | K121672 | Aft Proximal Humerus Fracture Plate | Shoulder Options, Inc. | 2012 | — |
| +1 | K133668 | Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture… | Shoulder Options, Inc. | 2014 | — |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +3 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 1…erus Fracture Plate issubstantially equivalent to the following devices: 510(k) Number Device J Manufacturer K041860 Synthes LCP Proximal Humerus Plate Synthes K011815 Synthes LCP Proximal Humerus Plate… | 2004 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 1…0(k) Number Device J Manufacturer K041860 Synthes LCP Proximal Humerus Plate Synthes K011815 Synthes LCP Proximal Humerus Plate Synthes K963172 Synthes 4.5mm Non-Locking Cannulate… | 2001 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 1…K041860 Synthes LCP Proximal Humerus Plate Synthes K011815 Synthes LCP Proximal Humerus Plate Synthes K963172 Synthes 4.5mm Non-Locking Cannulated yte ScrewSnte K042… | 1996 |
| * | K042695 | NCB Plating SystemSummary page 1…Plate Synthes K963172 Synthes 4.5mm Non-Locking Cannulated yte ScrewSnte K042695 4.5mm NCB Proximal Humerus Non- Zme Locking Screw… | 2004 |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K133668 (Shoulder Options, Inc., 2014) has gone furthest, with 16 descendants of its own.
- 35 other devices also cite its predicate K041860.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 AFTm Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121672: Aft Proximal Humerus Fracture Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121672
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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