510(k) · Cleared
ClearedSynthes Locking Calcaneal Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Jun 11, 1999 as substantially equivalent to K981372 (Synthes (Usa), 1998) after a 50-day review. Its family tree reaches back 1 generation to 1998. 1 of the 711 devices in its family, counting itself, has a Class I recall. 709 later devices descend from it.
- Decided
- Jun 11, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981372 (1998). 709 later devices descend from it, 16 citing it directly. 1 of the 711 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- This deviceK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- Descendant · cites it directly · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
Showing 5 of 709 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 709 · See all- K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · cites it directly690descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 2 generations on501descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| 0 (this device) | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| +1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| +2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +2 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
| +2 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 11 | 0 |
| 2011 | 15 | 0 |
| 2012 | 20 | 0 |
| 2013 | 29 | 0 |
| 2014 | 36 | 0 |
| 2015 | 41 | 0 |
| 2016 | 30 | 0 |
| 2017 | 51 | 0 |
| 2018 | 31 | 0 |
| 2019 | 37 | 0 |
| 2020 | 41 | 0 |
| 2021 | 47 | 1 |
| 2022 | 41 | 0 |
| 2023 | 51 | 0 |
| 2024 | 66 | 0 |
| 2025 | 60 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K981372 | Synthes 3.0 MM PC-Fix SystemSummary page 1…usgnung Synthes Locking Calcaneal Plates Plate, fixation, bone Class II, 21 CFR 888.3030 Synthes Multiple Fragment Plate (preamendment) Synthes 3.0 mm PC-Fix™ System, (K981372). Synthes LCPs are designed to address complex fractures of the calcaneus and are applied to the lateral side. The plate has 15… | 1998 |
| * | — | Synthes Multiple Fragment Plate (preamendment) Named without a submission number |
What descends from it? (709)
See all 70916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | 2003 | 690 |
| K051642 | FR.O.H. Calcaneus Repair System | 2005 | 28 |
| K110908 | Aptus Foot 3.5 System | 2011 | 25 |
| K041786 | Calcamea Plate | 2004 | 13 |
| K090582 | Calcaneal Fracture Plate System | 2009 | 12 |
| K071105 | Osteomed Calcaneal Plate and Screw Fixation System | 2007 | 9 |
| K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System | 2013 | 8 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | 2026 | 0 |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K033669 (Smith & Nephew, Inc., 2003) has gone furthest, with 690 descendants of its own.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
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/K991407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991407: Synthes Locking Calcaneal Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991407
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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