510(k) · Cleared
Recalled · Class II · 2019Stratum™ Foot Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 16, 2018 as substantially equivalent to K063049 (Synthes (Usa), 2006) and 2 other predicates after a 94-day review. Its family tree reaches back 4 generations to 2004. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 16, 2018
- Review
- 94 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 4 generations to K041081 (2004). 7 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004 · Recalled
- 3 generations backK061748 Fragment Plate SystemHand Innovations, LLC · 2006
- 2 generations backK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
- 1 generation backK131670 Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and…Biomet, Inc. · 2013
- This deviceK182201 Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK212979 CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK213301 InCore Subtalar SystemNextremity Solutions, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK200785 Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc. · 2022 · cites it directly0descendants
- K213301InCore Subtalar SystemNextremity Solutions, Inc. · 2021 · cites it directly0descendants
- K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021 · cites it directly0descendants
- K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041081 | Fragment Plate System, Screws, Pins and K-Wires | Hand Innovations, Inc. | 2004 | 1 |
| −3 | K061748 | Fragment Plate System | Hand Innovations, LLC | 2006 | — |
| −2 | K101240 | Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021… | DePuy Orthopaedics, Inc. | 2010 | — |
| −1 | K131670 | Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right) | Biomet, Inc. | 2013 | — |
| 0 (this device) | K182201 | Stratum™ Foot Plating System | Nextremity Solutions, Inc. | 2018 | — |
| +1 | K212979 | CalcShift™ Displacement Calcaneal Osteotomy System | Nextremity Solutions, Inc. | 2022 | — |
| +1 | K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | 2021 | — |
| +1 | K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021 | — |
| +1 | K200785 | Stratum™ Reduced Size Foot Plating System | Nextremity Solutions, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…Class II Product Codes: 87/HRS, 87/HWC Substantially Equivalent Devices: Synthes, Inc. Modular Mini Fragment LCP System, K063049 Nextremity Solutions MSP Metatarsal Shortening System, K140724 Biomet A… | 2006 |
| * | K140724 | MSP Metatarsal Shortening SystemSummary page 4…Equivalent Devices: Synthes, Inc. Modular Mini Fragment LCP System, K063049 Nextremity Solutions MSP Metatarsal Shortening System, K140724 Biomet A.L.P.S. Small Bone Locked Plating System, K131670 Device Description: The Stratum™ Foot P… | 2014 |
| * | K131670 | Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)Summary page 4… Nextremity Solutions MSP Metatarsal Shortening System, K140724 Biomet A.L.P.S. Small Bone Locked Plating System, K131670 Device Description: The Stratum™ Foot Plating System is a foot and ankle plating system consisting of plate and screw implants… | 2013 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2019 | Class II | Z-1127-2020 | Under Investigation by firm | The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate. |
| Nov 11, 2019 | Class II | Z-0776-2020 | Packaging process control | Components 2mm shorter than indicated on the package label |
| Nov 11, 2019 | Class II | Z-0777-2020 | Packaging process control | Components 2mm shorter than indicated on the package label |
| Nov 11, 2019 | Class II | Z-0778-2020 | Packaging process control | Components 2mm shorter than indicated on the package label |
| Oct 9, 2019 | Class II | Z-0534-2020 | Labeling mix-ups | Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K212979 (Nextremity Solutions, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 39 other devices also cite its predicate K063049.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for
fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone
segments, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182201: Stratum™ Foot Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182201
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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