510(k) · Cleared
ClearedLapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 3, 2013 as substantially equivalent to K101240 (DePuy Orthopaedics, Inc., 2010) and 2 other predicates after a 26-day review. Its family tree reaches back 3 generations to 2004. 5 later devices descend from it.
- Decided
- Jul 3, 2013
- Review
- 26 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K041081 (2004). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004 · Recalled
- 2 generations backK061748 Fragment Plate SystemHand Innovations, LLC · 2006
- 1 generation backK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
- This deviceK131670 Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and…Biomet, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK182201 Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK212979 CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK213301 InCore Subtalar SystemNextremity Solutions, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK200785 Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018 · cites it directly4descendants
- K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022 · 2 generations on0descendants
- K213301InCore Subtalar SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
- K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
- K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041081 | Fragment Plate System, Screws, Pins and K-Wires | Hand Innovations, Inc. | 2004 | 1 |
| −2 | K061748 | Fragment Plate System | Hand Innovations, LLC | 2006 | — |
| −1 | K101240 | Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021… | DePuy Orthopaedics, Inc. | 2010 | — |
| 0 (this device) | K131670 | Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right) | Biomet, Inc. | 2013 | — |
| +1 | K182201 | Stratum™ Foot Plating System | Nextremity Solutions, Inc. | 2018 | 5 |
| +2 | K212979 | CalcShift™ Displacement Calcaneal Osteotomy System | Nextremity Solutions, Inc. | 2022 | — |
| +2 | K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | 2021 | — |
| +2 | K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021 | — |
| +2 | K200785 | Stratum™ Reduced Size Foot Plating System | Nextremity Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K101240 | Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…Summary page 1…xtension is substantially equivalent to currently marketed systems ALPS Small Bone Locked Plating System (K(101240), LCL and Fusion Plating System (K(091294) and the Mini Fragment Plating System (K(061748). Devic… | 2010 |
| * | K091294 | Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010…Summary page 1…rrently marketed systems ALPS Small Bone Locked Plating System (K(101240), LCL and Fusion Plating System (K(091294) and the Mini Fragment Plating System (K(061748). Device Description: The ALPS Small Bone Locked Plating System Line… | 2009 |
| * | K061748 | Fragment Plate SystemSummary page 1…Bone Locked Plating System (K(101240), LCL and Fusion Plating System (K(091294) and the Mini Fragment Plating System (K(061748). Device Description: The ALPS Small Bone Locked Plating System Line Extension consists… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182201 | Stratum™ Foot Plating System | 2018 | 4 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K182201 (Nextremity Solutions, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K101240.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 -21 years of age)), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131670: Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131670
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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