510(k) · Cleared
ClearedSynthes LCP Proximal Tibia Plate
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 Aug 9, 2001 as substantially equivalent to K002361 (Synthes (Usa), 2000) after a 45-day review. Its family tree reaches back 1 generation to 2000. 1 of the 703 devices in its family, counting itself, has a Class I recall. 701 later devices descend from it.
- Decided
- Aug 9, 2001
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002361 (2000). 701 later devices descend from it, 16 citing it directly. 1 of the 703 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002361 Synthes (Usa) Locking Proximal Plating (L-PTP) SystemSynthes (Usa) · 2000
- This deviceK011978 Synthes LCP Proximal Tibia PlateSynthes (Usa) · 2001
- Descendant · cites it directly · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
Showing 5 of 701 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 701 · See all- K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · cites it directly690descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 2 generations on501descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002361 | Synthes (Usa) Locking Proximal Plating (L-PTP) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K011978 | Synthes LCP Proximal Tibia Plate | Synthes (Usa) | 2001 | — |
| +1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| +2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +2 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
| +2 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 11 | 0 |
| 2011 | 14 | 0 |
| 2012 | 20 | 0 |
| 2013 | 25 | 0 |
| 2014 | 38 | 0 |
| 2015 | 39 | 0 |
| 2016 | 30 | 0 |
| 2017 | 51 | 0 |
| 2018 | 32 | 0 |
| 2019 | 36 | 0 |
| 2020 | 41 | 0 |
| 2021 | 48 | 1 |
| 2022 | 41 | 0 |
| 2023 | 51 | 0 |
| 2024 | 66 | 0 |
| 2025 | 59 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K002361 | Synthes (Usa) Locking Proximal Plating (L-PTP) SystemSummary page 1…Hull (610) 647-9700 ext. 7191 Synthes LCP Proximal Tibia Plate Class II, §888.3030 - Plate, Fixation, Bone, Non-spinal, Metallic - Synthes Locking Proximal Tibia Plate (K002361) The Synthes LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profi… | 2000 |
What descends from it? (701)
See all 70116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | 2003 | 690 |
| K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | 2012 | 28 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K171904 | Tandry Locking Plate System | 2018 | 11 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND… | 2017 | 3 |
| K042237 | Ebi Periarticular Plating System | 2004 | 3 |
| K222282 | HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System | 2022 | 1 |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of… | 2016 | 1 |
| K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of… | 2015 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft 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/K011978 · printed Nov 3, 2026
Cite this page
510(k) Report. “K011978: Synthes LCP Proximal Tibia Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K011978
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026