510(k) · Cleared
ClearedSynthes Universal Locking Trochanter Stabilization Plate (Ultsp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Oct 12, 2005 after a 14-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Oct 12, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK052677 Synthes Universal Locking Trochanter Stabilization Plate (Ultsp)Synthes (Usa) · 2005
- Descendant · cites it directly · 2 of its ownK182783 DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
- Descendant · cites it directly · 2 of its ownK083582 Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009
- Descendant · 2 generations on · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK221787 Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
- Descendant · 2 generations on · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018 · cites it directly2descendants
- K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009 · cites it directly2descendants
- K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026 · 2 generations on0descendants
- K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023 · cites it directly0descendants
- K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052677 | Synthes Universal Locking Trochanter Stabilization Plate (Ultsp) | Synthes (Usa) | 2005 | — |
| +1 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +1 | K083582 | Sign Hip Construct (SHC), Model: 701 | Surgical Implant Generation Network (Sign) | 2009 | — |
| +2 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
| +1 | K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023 | — |
| +2 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | — | Synthes Trochanter Stabilization Plate (TSP) for DHS Named without a submission number |
What descends from it? (7)
3 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?
- Of its descendants, K182783 (DePuy Synthes, 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Synthes Universal Locking Trochanter Stabilization Plate for DHS®or LCP® DHHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP®Dynamic Helical Hip System (DHIHS) sideplates with four or more holes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052677: Synthes Universal Locking Trochanter Stabilization Plate (Ultsp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052677
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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