510(k) · Cleared
ClearedOptilock Periarticular Plating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Trauma · HRS Plate, Fixation, Bone
Cleared on Aug 5, 2009 as substantially equivalent to K061098 (Ebi, L.P., 2006) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Aug 5, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982222 (1998). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK982222 Synthes (Usa) Distal Femur Plate (DFP) SystemSynthes (Usa) · 1998
- 2 generations backK000066 Synthes (Usa) Locking Condylar Plate (LCP) SystemSynthes (Usa) · 2000
- 1 generation backK042237 Ebi Periarticular Plating SystemEbi, L.P. · 2004 · Recalled
- This deviceK092078 Optilock Periarticular PlatingBiomet Trauma · 2009
- Descendant · cites it directly · 1 of its ownK140018 TSP Hip Fracture Plating SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK173826 THP Hip Fracture Plating SystemBiomet, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982222 | Synthes (Usa) Distal Femur Plate (DFP) System | Synthes (Usa) | 1998 | — |
| −2 | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) System | Synthes (Usa) | 2000 | — |
| −1 | K042237 | Ebi Periarticular Plating System | Ebi, L.P. | 2004 | 10 |
| 0 (this device) | K092078 | Optilock Periarticular Plating | Biomet Trauma | 2009 | — |
| +1 | K140018 | TSP Hip Fracture Plating System | Biomet, Inc. | 2014 | 2 |
| +2 | 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K061098 | Ebi Optilock Periarticular Plating SystemSummary page 1…ne HWC, Screw, Fixation, Bone 'Class II Legally Marketed Device Cleared through K061098 on May 24, 2006 and K042237 on Information: September 16, 2004. Device Description… | 2006 |
| * | K042237 | Ebi Periarticular Plating SystemSummary page 1…HWC, Screw, Fixation, Bone 'Class II Legally Marketed Device Cleared through K061098 on May 24, 2006 and K042237 on Information: September 16, 2004. Device Description This submission is being… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140018 | TSP Hip Fracture Plating System | 2014 | 1 |
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 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140018 (Biomet, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K061098.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 EBI OptiLock Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System 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. The System is intended for the treatment of non-unions, malunions and fractures of the…
Read the full statement (179 words)
The EBI OptiLock Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.
The System 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.
The System 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.
The System 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 for the medial proximal tibia and tibial shaft.
The System 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/K092078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092078: Optilock Periarticular Plating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092078
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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