510(k) · Cleared
ClearedDepuy Ace Timax Meta 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 Dec 22, 1998 after a 53-day review. The FDA summary names its predicate without a number. 81 later devices descend from it.
- Decided
- Dec 22, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 5 citing it directly.
- This deviceK983853 Depuy Ace Timax Meta PlateDepuy Ace Medical Co. · 1998
- Descendant · cites it directly · 58 of its ownK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
- Descendant · cites it directly · 35 of its ownK041965 Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004
- Descendant · 3 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · 3 generations on · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly58descendants
- K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · 2 generations on55descendants
- K041965Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004 · cites it directly35descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 3 generations on19descendants
- K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983853 | Depuy Ace Timax Meta Plate | Depuy Ace Medical Co. | 1998 | — |
| +1 | K072832 | Anterolateral and Medial Locking Plating System | DePuy Orthopaedics, Inc. | 2007 | 2 |
| +2 | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates | Synthes (Usa) | 2010 | — |
| +1 | K041965 | Arthrex Humeral Fracture Plates and Screws | Arthrex, Inc. | 2004 | — |
| +3 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +3 | K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | Gpc Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 9 | 0 |
| 2026 | 11 | 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 Cloverleaf Plate, P/N 240.23 Named without a submission number |
What descends from it? (81)
See all 815 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, K072832 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 58 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?
Distal intra-articular tibia fractures
Proximal tibia fractures
Proximal and distal humerus fractures
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/K983853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983853: Depuy Ace Timax Meta Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983853
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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