510(k) · Cleared
ClearedStabiliz Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stabiliz Orthopaedics, LLC · HRS Plate, Fixation, Bone
Cleared on Nov 27, 2012 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 1 other predicate after a 270-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Nov 27, 2012
- Review
- 270 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000684 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- This deviceK120651 Stabiliz Fixation SystemStabiliz Orthopaedics, LLC · 2012
- Descendant · cites it directly · 0 of its ownK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| 0 (this device) | K120651 | Stabiliz Fixation System | Stabiliz Orthopaedics, LLC | 2012 | — |
| +1 | K130731 | Stabiliz Fixation System - SPL Locking Screw | Stabiliz Orthopaedics, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 2…supports the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684); and Zimmer® Universal Locking System (K0607110). Substantial Equivalence: The components of the Stabiiiz Fixation System are s… | 2000 |
| * | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130731 | Stabiliz Fixation System - SPL Locking Screw | 2013 | 0 |
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 3 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K130731 (Stabiliz Orthopaedics, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120651: Stabiliz Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120651
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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