510(k) · Cleared
ClearedSynthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates
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 May 11, 2010 as substantially equivalent to K080522 (Synthes (Usa), 2008) and 3 other predicates after a 239-day review. Its family tree reaches back 2 generations to 1988. 55 later devices descend from it.
- Decided
- May 11, 2010
- Review
- 239 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K882831 (1988). 8 ancestors in all. 55 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK882831 Ace Cancellous Bone ScrewBuckman Co., Inc. · 1988
- 1 generation backK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
- Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · cites it directly · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 11 of its ownK193633 APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020
- Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
- K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · cites it directly15descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020 · cites it directly11descendants
- K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882831 | Ace Cancellous Bone Screw | Buckman Co., Inc. | 1988 | — |
| −1 | K072832 | Anterolateral and Medial Locking Plating System | DePuy Orthopaedics, Inc. | 2007 | 2 |
| 0 (this device) | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates | Synthes (Usa) | 2010 | — |
| +1 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +1 | K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | Gpc Medical, Ltd. | 2016 | — |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +1 | K193633 | APTUS® Ankle Trauma System 2.8/3.5 | Medartis AG | 2020 | — |
| +2 | K193222 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T PlatesSummary page 1…/ multiple component metallic bone fixation appliance and accessories. Predicate Device: Synthes 3.5mm LCP Distal Tibia T Plates (K080522) Synthes LCP Distal Tibia Plates (K013248) Synthes Pilon Plate (K020602)… | 2008 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 1…on appliance and accessories. Predicate Device: Synthes 3.5mm LCP Distal Tibia T Plates (K080522) Synthes LCP Distal Tibia Plates (K013248) Synthes Pilon Plate (K020602) Depuy Orthopaedics, Inc. Anterolateral and… | 2001 |
| * | K020602 | Synthes Pilon PlateSummary page 1…Synthes 3.5mm LCP Distal Tibia T Plates (K080522) Synthes LCP Distal Tibia Plates (K013248) Synthes Pilon Plate (K020602) Depuy Orthopaedics, Inc. Anterolateral and Medial Locking Plating System… | 2002 |
| * | K072832 | Anterolateral and Medial Locking Plating SystemSummary page 1…Synthes Pilon Plate (K020602) Depuy Orthopaedics, Inc. Anterolateral and Medial Locking Plating System (K072832) Device Description: The Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are low… | 2007 |
What descends from it? (55)
See all 5510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162674 | BioPro Foot Plating Systems | 2017 | 19 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | 2020 | 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 |
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN… | 2015 | 1 |
| K242988 | Genostis Osteosynthesis System | 2025 | 0 |
| K232394 | Internal Locking Plate and Screw Fixation System | 2023 | 0 |
| K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®… | 2016 | 0 |
| K133675 | Aap Loqteq Distal Anterolateral Tibia Plate 3.5 | 2014 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K162674 (Biopro, Inc., 2017) has gone furthest, with 19 descendants of its own.
- 9 other devices also cite its predicate K080522.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092812
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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