510(k) · Cleared
Cleared4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous Locking Screws, Respectively.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 7, 2007 as substantially equivalent to K000682 (Synthes (Usa), 2000) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 7, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962616 (1996). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 3 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 2 generations backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
- 1 generation backK060969 Polyax Locked Plating SystemDePuy Orthopaedics, Inc. · 2006 · Recalled
- This deviceK072423 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM…DePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK103408 Posterior Lateral PlatesDePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK243761 A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025
- Descendant · 2 generations on · 0 of its ownK171372 Alians Elbow Locking Plating SystemNewclip Technics · 2018
Most influential descendants
Showing 4 of 4 · See all- K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc. · 2010 · cites it directly3descendants
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
- K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics · 2025 · 2 generations on0descendants
- K171372Alians Elbow Locking Plating SystemNewclip Technics · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −3 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −2 | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | 2 |
| −1 | K060969 | Polyax Locked Plating System | DePuy Orthopaedics, Inc. | 2006 | 10 |
| 0 (this device) | K072423 | 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical &… | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K103408 | Posterior Lateral Plates | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
| +2 | K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025 | — |
| +2 | K171372 | Alians Elbow Locking Plating System | Newclip Technics | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…(21 CFR § 888.3030) Predicate Devices: Large Fragment Dynamic Synthes K000682 Compression Locking System… | 2000 |
| * | K060969 | Polyax Locked Plating SystemSummary page 1…System POLYAX TM Locked Plating D~ePuy K060969 Sse System Intended Use: The Lar… | 2006 |
What descends from it? (4)
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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K103408 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 24 other devices also cite its predicate K000682.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072423 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072423: 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous Locking Screws, Respectively..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072423
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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