510(k) · Cleared
ClearedOsteoCentric Bone Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteocentric Trauma · HWC Screw, Fixation, Bone
Cleared on Mar 22, 2019 as substantially equivalent to K152000 (Smv Scientific, 2015) after a 28-day review. Its family tree reaches back 6 generations to 1998. 2 later devices descend from it.
- Decided
- Mar 22, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981372 (1998). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 2 generations backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- 1 generation backK152000 SMV Scientific Bone Plate and Screw SystemSmv Scientific · 2015
- This deviceK190430 OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma · 2019
- Descendant · cites it directly · 1 of its ownK250494 The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies · 2025
- Descendant · cites it directly · 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 |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −2 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| −1 | K152000 | SMV Scientific Bone Plate and Screw System | Smv Scientific | 2015 | — |
| 0 (this device) | K190430 | OsteoCentric Bone Plate and Screw System | Osteocentric Trauma | 2019 | — |
| +1 | K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies | 2025 | — |
| +1 | K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K152000 | SMV Scientific Bone Plate and Screw SystemSummary page 5…om 2.0mm – 4.5mm previously cleared to 2.0mm – 5.0mm. Predicate Devices 510k Trade or Proprietary or Model Name Manufacturer Number K152000 SMV Bone Plate and Screw System SMV Scientific Primary K150981 SMV Scientific Bone Sc… | 2015 |
| † | K150981 | SMV Scientific Bone Screws | 2015 |
| † | K150188 | SMV Scientific 4.5 mm Bone Screws | 2015 |
| † | K001945 | Synthes (Usa) Medial Distal Tibia Plates | 2000 |
| † | K011335 | Synths One-Third Tubular DCL Plate | 2001 |
| † | K020872 | Synthes 3.5 MM Broad LC-DCP Plates | 2002 |
| † | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications | 2008 |
| † | K010321 | Modular Foot System - 2.7 MM Module | 2001 |
| † | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) | 2009 |
| † | K092889 | Syntec Osteo-Plate and Screw Fixation | 2010 |
What descends from it? (2)
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 21 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 14 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 K152000.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190430: OsteoCentric Bone Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190430
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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