510(k) · Cleared
ClearedA.L.P.S. Calcaneal Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · HRS Plate, Fixation, Bone
Cleared on Nov 19, 2013 as substantially equivalent to K093474 (DePuy Orthopaedics, Inc., 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1992. 11 later devices descend from it.
- Decided
- Nov 19, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915818 (1992). 9 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 3 generations backK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
- 2 generations backK041786 Calcamea PlateNew Deal, S.A. · 2004
- 1 generation backK090582 Calcaneal Fracture Plate SystemTornier, Inc. · 2009
- This deviceK132898 A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013
- Descendant · cites it directly · 6 of its ownK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · cites it directly · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018 · cites it directly6descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
- K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · cites it directly1descendant
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · 2 generations on1descendant
- K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −3 | K981775 | Depuy Ace Timax Calcaneal Peri-Articular Plate | Depuy Ace Medical Co. | 1998 | — |
| −2 | K041786 | Calcamea Plate | New Deal, S.A. | 2004 | — |
| −1 | K090582 | Calcaneal Fracture Plate System | Tornier, Inc. | 2009 | — |
| 0 (this device) | K132898 | A.L.P.S. Calcaneal Plating System | Biomet Manufacturing Corp | 2013 | — |
| +1 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +1 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +2 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +3 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K093474 | Depuy Fracture and Fusion Plating SystemSummary page 1…component metallic bone fixation appliances and accessories Legally marketed device(s) to DePuy Fracture and Fusion Plating System (K093474), which equivalence isclaimed DePuy Calcaneal Plate (K(993465), Tornier Calcaneal Fracture Pl… | 2010 |
| Kept off the family tree | K093465 | FDA’s K093465 is Fusion System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K090582 | Calcaneal Fracture Plate SystemSummary page 1…on Plating System (K093474), which equivalence isclaimed DePuy Calcaneal Plate (K(993465), Tornier Calcaneal Fracture Plate System (K(090582) Reason for 510(k) submission New Device Construct Device description The new A.L.P.S calcaneal plating system is… | 2009 |
| * | — | A.L.P.S screw system Named without a submission number |
What descends from it? (11)
See all 114 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 21 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K171808 (Tdm Co., Ltd., 2018) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K093474.
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 Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132898: A.L.P.S. Calcaneal Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132898
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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