510(k) · Cleared
ClearedOsteomed Calcaneal Plate and Screw Fixation 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 Jul 30, 2007 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 1 other predicate after a 102-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it.
- Decided
- Jul 30, 2007
- Review
- 102 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981372 (1998). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 1 generation backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- This deviceK071105 Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP · 2007
- Descendant · cites it directly · 8 of its ownK131445 Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
- Descendant · 2 generations on · 2 of its ownK191009 Arsenal Plating SystemTrilliant Surgical · 2019
- Descendant · 2 generations on · 2 of its ownK133437 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 ownK251709 MedCAD® AccuStride™ SystemMedcad · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131445Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013 · cites it directly8descendants
- K191009Arsenal Plating SystemTrilliant Surgical · 2019 · 2 generations on2descendants
- K1334371ST MTP PlateOsteomed · 2013 · 2 generations on2descendants
- K143365Eminent Foot Plate SystemEminent Spine · 2015 · cites it directly1descendant
- K251709MedCAD® AccuStride™ SystemMedcad · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −1 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| 0 (this device) | K071105 | Osteomed Calcaneal Plate and Screw Fixation System | Osteomed LP | 2007 | — |
| +1 | K131445 | Osteomed Extremilock Foot Plating System | Osteomed LP | 2013 | — |
| +2 | K191009 | Arsenal Plating System | Trilliant Surgical | 2019 | — |
| +2 | K133437 | 1ST MTP Plate | Osteomed | 2013 | — |
| +1 | K143365 | Eminent Foot Plate System | Eminent Spine | 2015 | — |
| +2 | K251709 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 1…e system. Equivalence for this device is based on similarities in intended use, material, design and operational principle to: Synthes K991407, New Deal KC41786 and Darco, K061808. Due to the similarity of materials and design to both pr… | 1999 |
| Kept off the family tree | K041786 | FDA’s K041786 is Calcamea Plate Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…e is based on similarities in intended use, material, design and operational principle to: Synthes K991407, New Deal KC41786 and Darco, K061808. Due to the similarity of materials and design to both pre-enactment and post- enactment devic… | 2006 |
What descends from it? (9)
2 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 9 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K131445 (Osteomed LP, 2013) has gone furthest, with 8 descendants of its own.
- 15 other devices also cite its predicate K991407.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures. Plates and screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071105: Osteomed Calcaneal Plate and Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071105
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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