510(k) · Cleared
Recalled · 2009Ebi Periarticular Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · HRS Plate, Fixation, Bone
Cleared on Sep 16, 2004 as substantially equivalent to K000066 (Synthes (Usa), 2000) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it. It has been recalled 10 times.
- Decided
- Sep 16, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 10
- Predicates
- 4
Its longest line of descent runs back 2 generations to K982222 (1998). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK982222 Synthes (Usa) Distal Femur Plate (DFP) SystemSynthes (Usa) · 1998
- 1 generation backK000066 Synthes (Usa) Locking Condylar Plate (LCP) SystemSynthes (Usa) · 2000
- This deviceK042237 Ebi Periarticular Plating SystemEbi, L.P. · 2004
- Descendant · cites it directly · 2 of its ownK092078 Optilock Periarticular PlatingBiomet Trauma · 2009
- Descendant · 2 generations on · 1 of its ownK140018 TSP Hip Fracture Plating SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK173826 THP Hip Fracture Plating SystemBiomet, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982222 | Synthes (Usa) Distal Femur Plate (DFP) System | Synthes (Usa) | 1998 | — |
| −1 | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K042237 | Ebi Periarticular Plating System | Ebi, L.P. | 2004 | — |
| +1 | K092078 | Optilock Periarticular Plating | Biomet Trauma | 2009 | — |
| +2 | K140018 | TSP Hip Fracture Plating System | Biomet, Inc. | 2014 | 2 |
| +3 | K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 1…Accessories, 21 CFR 888.3030 3. Predicate or legally marketed devices that are substantially equivalent: o Synthes Locking Condylar Plate (LCP) System (K000066) o Synthes Large Fragment LCP System - T Plate (KO10766) o Synthes LCP Proximal Tibia Plate System… | 2000 |
| * | K010766 | Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate | 2001 |
| * | K011978 | Synthes LCP Proximal Tibia Plate | 2001 |
| * | K013248 | Synthes LCP Distal Tibia Plates | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092078 | Optilock Periarticular Plating | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-2292-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2298-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2293-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2294-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2296-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2297-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2299-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2295-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2291-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2290-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K092078 (Biomet Trauma, 2009) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K000066.
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 EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations: Distal Femoral Plate The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone and nonunions and malunions. Proximal…
Read the full statement (208 words)
The EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations:
Distal Femoral Plate
The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone and nonunions and malunions.
Proximal Lateral Tibial Plate
The Proximal Lateral Tibial Plate is intended for the 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.
Proximal Medial Tibial Plate
The Proximal Medial Tibial Plate is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
Distal Tibia Plate
The Distal Tibial Plate is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042237 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042237: Ebi Periarticular Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042237
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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