510(k) · Cleared
Recalled · Class II · 2024DePuy Synthes 2.7mm VA LCP Clavicle Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · HRS Plate, Fixation, Bone
Cleared on Jul 24, 2020 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 1 other predicate after a 67-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 2020
- Review
- 67 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000684 (2000). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 2 generations backK101536 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSynthes (Usa), LLC · 2010
- 1 generation backK111540 Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
- This deviceK201321 DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes · 2020
- Descendant · cites it directly · 1 of its ownK203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes…DePuy Synthes · 2020
- Descendant · 2 generations on · 0 of its ownK240181 Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK230805 TriMed Clavicle Fixation SystemTriMed, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…DePuy Synthes · 2020 · cites it directly1descendant
- K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024 · 2 generations on0descendants
- K230805TriMed Clavicle Fixation SystemTriMed, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −2 | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System | Synthes (Usa), LLC | 2010 | — |
| −1 | K111540 | Synthes 3.5MM LCP Clavicle Plate System | Synthes (Usa) | 2011 | — |
| 0 (this device) | K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | DePuy Synthes | 2020 | — |
| +1 | K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP… | DePuy Synthes | 2020 | — |
| +2 | K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | 2024 | — |
| +1 | K230805 | TriMed Clavicle Fixation System | TriMed, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…Class II Classification Regulation Number: 21 CFR 888.3030 Product Code: HRS Primary Synthes LCP Reconstruction Plate 3.5 (K000684) predicate device Secondary Synthes 3.5mm LCP Clavicle Plate System (K111540) predicate device… | 2000 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 4…ode: HRS Primary Synthes LCP Reconstruction Plate 3.5 (K000684) predicate device Secondary Synthes 3.5mm LCP Clavicle Plate System (K111540) predicate device The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and… | 2011 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2024 | Class II | Z-1241-2024 | Process control | Products not sterilized, sterility cannot be confirmed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K203414 (DePuy Synthes, 2020) has gone furthest, with 1 descendant of its own.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, osteotomies, and non-unions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
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/K201321 · printed Nov 4, 2026
Cite this page
510(k) Report. “K201321: DePuy Synthes 2.7mm VA LCP Clavicle Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K201321
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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