510(k) · Cleared
ClearedOsteomed Extremilock Foot Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · HRS Plate, Fixation, Bone
Cleared on Jun 18, 2013 as substantially equivalent to K091614 (Osteomed LP, 2009) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1998. 8 later devices descend from it.
- Decided
- Jun 18, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981372 (1998). 6 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 2 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 1 generation backK071105 Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP · 2007
- This deviceK131445 Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
- Descendant · cites it directly · 2 of its ownK191009 Arsenal Plating SystemTrilliant Surgical · 2019
- Descendant · cites it directly · 2 of its ownK133437 1ST MTP PlateOsteomed · 2013
- Descendant · cites it directly · 1 of its ownK143365 Eminent Foot Plate SystemEminent Spine · 2015
- Descendant · cites it directly · 0 of its ownK251709 MedCAD® AccuStride™ SystemMedcad · 2025
- Descendant · 2 generations on · 0 of its ownK212378 Arsenal Ankle Plating SystemTrilliant Surgical · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K191009Arsenal Plating SystemTrilliant Surgical · 2019 · cites it directly2descendants
- K1334371ST MTP PlateOsteomed · 2013 · cites it directly2descendants
- K143365Eminent Foot Plate SystemEminent Spine · 2015 · cites it directly1descendant
- K251709MedCAD® AccuStride™ SystemMedcad · 2025 · cites it directly0descendants
- K212378Arsenal Ankle Plating SystemTrilliant Surgical · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −2 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −1 | K071105 | Osteomed Calcaneal Plate and Screw Fixation System | Osteomed LP | 2007 | — |
| 0 (this device) | K131445 | Osteomed Extremilock Foot Plating System | Osteomed LP | 2013 | — |
| +1 | K191009 | Arsenal Plating System | Trilliant Surgical | 2019 | — |
| +1 | K133437 | 1ST MTP Plate | Osteomed | 2013 | — |
| +1 | K143365 | Eminent Foot Plate System | Eminent Spine | 2015 | — |
| +1 | K251709 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +2 | K212378 | Arsenal Ankle Plating System | Trilliant Surgical | 2022 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K091614 | Osteomed Foot Plating SystemSummary page 1…me:; ' 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS Predicate Devices: QOsteoMed Foot Plating System, K091614 Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HR… | 2009 |
| * | K071105 | Osteomed Calcaneal Plate and Screw Fixation SystemSummary page 1…e/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Device Class: 1T OsteoMed Calcaneal Plate and Screw Fixation, K071105 Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HR… | 2007 |
What descends from it? (8)
5 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)
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 2 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K191009 (Trilliant Surgical, 2019) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K091614.
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 ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for
the size of the device.
The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use
only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131445: Osteomed Extremilock Foot Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131445
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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