510(k) · Cleared
ClearedA.L.P.S. Clavicle Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 19, 2021 as substantially equivalent to K173767 (Biomet, Inc., 2018) after a 25-day review. Its family tree reaches back 2 generations to 2009. 2 later devices descend from it.
- Decided
- Feb 19, 2021
- Review
- 25 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083843 (2009). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK083843 Locking Anatomic & Composite Plating SystemDePuy Orthopaedics, Inc. · 2009 · Recalled
- 1 generation backK173767 A. L. P. S. Clavicle Plating SystemBiomet, Inc. · 2018 · Recalled
- This deviceK210192 A.L.P.S. Clavicle Plating SystemBiomet, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK250494 The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies · 2025
- Descendant · 2 generations on · 0 of its ownK251913 OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies · 2025
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 |
|---|---|---|---|---|---|
| −2 | K083843 | Locking Anatomic & Composite Plating System | DePuy Orthopaedics, Inc. | 2009 | 2 |
| −1 | K173767 | A. L. P. S. Clavicle Plating System | Biomet, Inc. | 2018 | 2 |
| 0 (this device) | K210192 | A.L.P.S. Clavicle Plating System | Biomet, Inc. | 2021 | — |
| +1 | K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies | 2025 | — |
| +2 | K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K173767 | A. L. P. S. Clavicle Plating SystemSummary page 4…metallic bone fixation appliances and accessories (21 CFR 888.3030) Predicate Device(s): K173767 A.L.P.S. Clavicle Biomet Inc. Plating System Purpose and D… | 2018 |
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 |
|---|---|---|---|
| K250494 | The OsteoCentric Bone Plate and Screw System | 2025 | 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 12 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K250494 (OsteoCentric Technologies, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173767.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle including osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210192: A.L.P.S. Clavicle 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/K210192
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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