510(k) · Cleared
ClearedAft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul
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 Mar 3, 2014 as substantially equivalent to K121672 (Shoulder Options, Inc., 2012) and 2 other predicates after a 94-day review. Its family tree reaches back 3 generations to 1996. 16 later devices descend from it.
- Decided
- Mar 3, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961413 (1996). 8 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 2 generations backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- 1 generation backK121672 Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012
- This deviceK133668 Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity…Shoulder Options, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| −2 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| −1 | K121672 | Aft Proximal Humerus Fracture Plate | Shoulder Options, Inc. | 2012 | — |
| 0 (this device) | K133668 | Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture… | Shoulder Options, Inc. | 2014 | — |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K121672 | Aft Proximal Humerus Fracture PlateSummary page 1…he Shoulder Options AFTm Greater Tuberosity Fracture System is substantially equivalent to the following devices: §erfatre K121672 Shoulder Options AFT Proximal Humerus Sole pin Fracture Plate… | 2012 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 1…§erfatre K121672 Shoulder Options AFT Proximal Humerus Sole pin Fracture Plate K963172 Synthes 4.5mm Cannulated Screw Synthes K052483 Synthes Spherical Wa… | 1996 |
| * | K052483 | Synthes (Usa) Spherical WashersSummary page 1…Sole pin Fracture Plate K963172 Synthes 4.5mm Cannulated Screw Synthes K052483 Synthes Spherical Washers Synthes… | 2005 |
What descends from it? (16)
See all 162 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 18 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K121672.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 AFT Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT Greater Tuberosity 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/K133668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133668
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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