510(k) · Cleared
ClearedMedical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 15, 2010 as substantially equivalent to K082300 (DePuy Orthopaedics, Inc., 2009) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1988. 32 later devices descend from it.
- Decided
- Jun 15, 2010
- Review
- 26 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K882831 (1988). 5 ancestors in all. 32 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK882831 Ace Cancellous Bone ScrewBuckman Co., Inc. · 1988
- 1 generation backK072083 Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK101421 Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon…DePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
- Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · cites it directly17descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
- K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · cites it directly11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882831 | Ace Cancellous Bone Screw | Buckman Co., Inc. | 1988 | — |
| −1 | K072083 | Small Fragment Locking Plating System | DePuy Orthopaedics, Inc. | 2007 | 2 |
| 0 (this device) | K101421 | Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates… | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing | 2015 | 18 |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +1 | K113733 | Small and Large Fragments Osteosynthesis System Neofix | Neoortho Produtos Ortopedicos S/A | 2012 | — |
| +3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K082300 | Anatomic Locking Plating SystemSummary page 1…tantially equivalent to the currently marketed DePuy Predicate Anatomic Locked Plating System Long Plate Line Extension System, Devices K082300 and DePuy's Small Fragment Locking Plating System K072083. Classification Class 11,21 CFR 888.3030 Performance… | 2009 |
| * | K072083 | Small Fragment Locking Plating SystemSummary page 1…cate Anatomic Locked Plating System Long Plate Line Extension System, Devices K082300 and DePuy's Small Fragment Locking Plating System K072083. Classification Class 11,21 CFR 888.3030 Performance Performance standards have not been established… | 2007 |
What descends from it? (32)
See all 323 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 22 years and passes through 2 companies; a new generation was cleared every 19.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K143697 (Biomet Manufacturing, 2015) has gone furthest, with 17 descendants of its own.
- 9 other devices also cite its predicate K082300.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 DePuly Anatomic Locked Plating System Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101421
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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