510(k) · Cleared
Cleared1ST MTP Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · HRS Plate, Fixation, Bone
Cleared on Dec 2, 2013 as substantially equivalent to K131445 (Osteomed LP, 2013) after a 25-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 2, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981372 (1998). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK071105 Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP · 2007
- 1 generation backK131445 Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
- This deviceK133437 1ST MTP PlateOsteomed · 2013
- Descendant · cites it directly · 1 of its ownK143365 Eminent Foot Plate SystemEminent Spine · 2015
- Descendant · 2 generations on · 0 of its ownK152548 AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K071105 | Osteomed Calcaneal Plate and Screw Fixation System | Osteomed LP | 2007 | — |
| −1 | K131445 | Osteomed Extremilock Foot Plating System | Osteomed LP | 2013 | — |
| 0 (this device) | K133437 | 1ST MTP Plate | Osteomed | 2013 | — |
| +1 | K143365 | Eminent Foot Plate System | Eminent Spine | 2015 | — |
| +2 | K152548 | AXI+LINE Proximal Bunion Correction System | Nextremity Solutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K131445 | Osteomed Extremilock Foot Plating SystemSummary page 1…fixation appliances and accessories Product Code: HRS Predicate Devices: OsteoMed ExtremiLOCK Foot Plating System. K131445 Classification Name: Single/multiple component metallic bone fixation… | 2013 |
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 |
|---|---|---|---|
| K143365 | Eminent Foot Plate System | 2015 | 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 15 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K143365 (Eminent Spine, 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K131445.
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?
The OsteoMed ExtremiLaCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the root ankle or other bones appropriate for the size of the device.
The OsteoMed ExtrendLOCK Foot Plating System implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133437 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133437: 1ST MTP Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133437
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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