510(k) · Cleared
ClearedDepuy Ace Trochanteric Side Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ace Medical Co. · HRS Plate, Fixation, Bone
Cleared on Apr 30, 1997 after a 79-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Apr 30, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK970503 Depuy Ace Trochanteric Side PlateDepuy Ace Medical Co. · 1997
- Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
- K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 2 generations on1descendant
- K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 2 generations on1descendant
- K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970503 | Depuy Ace Trochanteric Side Plate | Depuy Ace Medical Co. | 1997 | — |
| +1 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| +2 | K063709 | TS-Bone Hip Tool | Orthopedic Sciences, Inc. | 2007 | — |
| +2 | K040850 | Tsy Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2004 | — |
| +2 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | DePuy ACE Captured Hip Screw Side Plate Named without a submission number |
What descends from it? (10)
2 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, K022139 (Orthopedic Sciences, Inc., 2002) has gone furthest, with 7 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 DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970503: Depuy Ace Trochanteric Side Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970503
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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