510(k) · Cleared
ClearedAUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical · HRS Plate, Fixation, Bone
Cleared on Jun 30, 2015 as substantially equivalent to K012114 (Synthes (Usa), 2001) and 16 other predicates after a 372-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jun 30, 2015
- Review
- 372 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 17
Its longest line of descent runs back 5 generations to K981372 (1998). 33 ancestors in all, the oldest K882831 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- This deviceK141680 AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS…Auxein Medical · 2015
- Descendant · cites it directly · 0 of its ownK201510 Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V. · 2022
Most influential descendants
Showing 1 of 1 · See all- K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −1 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| 0 (this device) | K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System… | Auxein Medical | 2015 | — |
| +1 | K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | Fixier S.A. DE C.V. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (17)
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 |
|---|---|---|---|
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 7…their corresponding predicate devices. S.N. Item Description Predicate Device 1. 2.4mm Wise-Lock "T" Distal Radius Dorsal K012114 (Synthes locking distal Plate, (3 Head Holes) radius plating system) 2. 2.4mm Wise-Lock D… | 2001 |
| * | K040777 | LCP Radial Head Plating SystemSummary page 7…radius plating system) 2. 2.4mm Wise-Lock Distal Radius Volar LCP Radial Head Plating Plate, Extra-Articular, Left, (4 Head Holes) System (K040777) 3. 2.4mm Wise-Lock Distal Radius Volar LCP Radial Head Plating Plate, Extra-Articular, Right, (4 Head… | 2004 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 7…ystem (K040777) 4. 2.7/3.5mm Wise-Lock Dorsolateral Distal Synthes 3.5mm LCP Distal Humerus Plate, Left Direction Humerus System (K033995) 5. 2.7/3.5mm Wise-Lock Dorsolateral Distal Synthes 3.5mm LCP Distal Humerus Plate, Right Direction… | 2004 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 7…95) Direction 8. 2.7/3.5mm Wise-Lock Medial Distal Tibia Synthes Medial Distal Tibia Plate Plate, Left Direction (K001945) 9. 2.7/3.5mm Wise-Lock Medial Distal Tibia Synthes Medial Distal Tibia Plate Plate, Right Direction… | 2000 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 7…Synthes (USA) LCP® Proximal Plate Humerus Plates, Long (K041860) 11. 3.5mm Wise-Lock Small Dynamic Synthes 3.5 and 4.5mm Locking Compression Plate with LC under c… | 2004 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 8…K141680 page 5 of 11 AUXEIN MEDICAL (K082807) 12. 3.5mm Wise-Lock Proximal Humerus Plate Proximal humerus plate long… | 2008 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 8…Synthes Small Fragment Dynamic Angled - Left Direction Compression Locking( DCL) System (K000684) 14. 3.5mm Wise-Lock Small 'T' Plate, Oblique Synthes Small Fragment Dynamic Angled - Right Direction… | 2000 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 8…System(K000684) 17. 3.5mm Wise-Lock Proximal Tibia Plate, Left Synthes 3.5mm Titanium LCP Direction Proximal Tibia Plate (K030597) OR Synthes LCP Proximal Tibia… | 2003 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 8…roximal Tibia Plate (K030597) OR Synthes LCP Proximal Tibia Plates (K011978) 18. 3.5mm Wise-Lock Proximal Tibia Plate, Synthes 3.5mm Titanium LCP Right Direction… | 2001 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 8…Synthes (USA) 2.7mm / 3.5mm Plates, Left LCP Anterolateral Distal Tibia Plates (K092812) 20. 3.5mm Wise-Lock Anterolateral Distal Tibia Synthes (USA) 2.7mm / 3.5mm Plates, Right… | 2010 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 8…Plates (K092812) 21. 3.5mm Wise-Lock Clavicle Hook Plate, Left Synthes Clavicle Hook Plate Direction (K061753) 22. 3.5mm Wise-Lock Clavicle Hook Plate, Synthes Clavicle Hook Plate Right Direction… | 2006 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 9…Curved Narrow and Broad Locking Compression Plates (LCP) (K092609) 24. 4.5/5.0mm Wise-Lock Reconstruction Synthes 4.5 mm LCP Straight Plates R… | 2009 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 9…(LCP) (K092609) 24. 4.5/5.0mm Wise-Lock Reconstruction Synthes 4.5 mm LCP Straight Plates Reconstruction Plate (K051986) 25. 4.5/5.0mm Wise Lock Broad Locking Synthes 3.5 and 4.5mm Locking Compression Plate… | 2005 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 9…(K082807) 27. 4.5/5.0mm Wise lock Distal Femur Plate Synthes LCP Distal Femur Plates (K062564) 28. 4.5/5.0mm Wise Lock Lateral Tibia Plate Synthes LCP Proximal Tibia Pl… | 2006 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 9…oximal Femur plate Synthes (USA) LCP Proximal Femur Plate and Screws (K030858) 30. 2.4mm Wise Lock Screw Synthes 2.4mm titanium lockin… | 2003 |
| * | K033975 | Synthes 2.4 MM Titanium (TI.) Locking ScrewsSummary page 9…e Lock Screw Synthes 2.4mm titanium locking screw (K033975) 31. 2.7 mm Wise Lock Screw Synthes Small Fragment Dynami… | 2004 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 9…Synthes Large Fragment Dynamic Compression Locking (DCL) System (K000682) 6 K1416… | 2000 |
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 |
|---|---|---|---|
| K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | 2022 | 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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 33 ancestors have a recall of any class.
- Of its descendants, K201510 (Fixier S.A. DE C.V., 2022) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K012114.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws. AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia…
Read the full statement (158 words)
AUXEIN Brand of Bone plates and bone screws are provided non-sterile.
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws.
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141680: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141680
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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