510(k) · Cleared
ClearedStabiliz Fixation System - SPL Locking Screw
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 Jul 19, 2013 as substantially equivalent to K120651 (Stabiliz Orthopaedics, LLC, 2012) and 4 other predicates after a 123-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Jul 19, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K981372 (1998). 38 ancestors in all, the oldest K911837 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 6 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 5 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 3 generations backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
- 2 generations backK113718 NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012 · Recalled
- 1 generation backK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- This deviceK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −6 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −5 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −4 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −3 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
| −2 | K113718 | NCB Straight Narrow Shaft Plates | Zimmer GmbH | 2012 | 1 |
| −1 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| 0 (this device) | K130731 | Stabiliz Fixation System - SPL Locking Screw | Stabiliz Orthopaedics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (5)
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 |
|---|---|---|---|
| * | K120651 | Stabiliz Fixation SystemSummary page 2…e Devices: Data provided in the 5 10(k) support the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Stabiliz Fixation System (K 12065 1); Zimmer® MotionLoc Screws (K 123918 and K 10 1696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb… | 2012 |
| * | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate SystemSummary page 2…) support the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Stabiliz Fixation System (K 12065 1); Zimmer® MotionLoc Screws (K 123918 and K 10 1696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb® Tibia! L-15 Screw and Washer (K0332… | 2013 |
| * | K101696 | Motionloc Screw for NCB Polyaxial Locking Plating SystemSummary page 2…substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Stabiliz Fixation System (K 12065 1); Zimmer® MotionLoc Screws (K 123918 and K 10 1696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb® Tibia! L-15 Screw and Washer (K033233). Substant… | 2010 |
| * | K020872 | Synthes 3.5 MM Broad LC-DCP PlatesSummary page 2…ion System to the following predicate devices: Stabiliz Fixation System (K 12065 1); Zimmer® MotionLoc Screws (K 123918 and K 10 1696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb® Tibia! L-15 Screw and Washer (K033233). Substantial Equivalence: The components of the Stabi… | 2002 |
| * | K033233 | Lactosorb Tibial L-15 Screw and WasherSummary page 2…12065 1); Zimmer® MotionLoc Screws (K 123918 and K 10 1696); Synthes 3.5mm Broad LC-DCP Plate (K020872); and Biomet Orthopedics Lactosorb® Tibia! L-15 Screw and Washer (K033233). Substantial Equivalence: The components of the Stabiliz Fixation System are substantially equivalent to the identified predica… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 38 ancestors have a recall of any class.
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 Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130731: Stabiliz Fixation System - SPL Locking Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130731
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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