510(k) Report

510(k) · Cleared

Cleared

Traufix osteosynthesis, osteotomy, and arthrodesis devices

K201510510(k) TraditionalCleared Feb 18, 2022623-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fixier S.A. DE C.V. · HRS Plate, Fixation, Bone

Cleared on Feb 18, 2022 as substantially equivalent to K141680 (Auxein Medical, 2015) and 6 other predicates after a 623-day review. Its family tree reaches back 6 generations to 1998.

Decided
Feb 18, 2022
Review
623 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K981372 (1998). 37 ancestors in all, the oldest K882831 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 3 other ancestors2005: 1 other ancestor2004: 5 other ancestors2001: 4 other ancestors2000: 5 other ancestors2010: 1 other ancestor2003: 2 other ancestors2008: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1991: 1 other ancestor1988: 1 other ancestorK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K092609 · Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) · Synthes (Usa) · 2009K141680 · AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws · Auxein Medical · 20151990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 7 other ancestors4 generations back: 5 other ancestors5 generations back: 1 other ancestor K141680 · AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws · Auxein Medical · 2015K092609 · Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) · Synthes (Usa) · 2009K082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998−50
  1. Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. 2 generations backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
  6. 1 generation backK141680 AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS…Auxein Medical · 2015
  7. This deviceK201510 Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−5K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−4K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−3K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
−2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates…Synthes (Usa)2009—
−1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System…Auxein Medical2015—
0 (this device)K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199820
199920
200050
200140
200210
200320
200450
200510
200630
200720
200810
201010
FIG. 1 — Lineage of K201510, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…
Summary page 7
…Bone Screws & AUXEIN Device: BRAND Of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws, (K141680) .Page  of  Fixier…
Auxein Medical2015—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 8
…ix osteosynthesis, osteotomy and arthrodesis devices February 15, 2022 Other Predicate -Synthes (USA) Modular Mini Fragment LCP System, (K063049) Devices: -Synthes (USA) Medial Distal Tibia Plates, (K001945) -Synthes Variable…
Synthes (Usa)20064
*K001945Synthes (Usa) Medial Distal Tibia Plates
Summary page 8
…5, 2022 Other Predicate -Synthes (USA) Modular Mini Fragment LCP System, (K063049) Devices: -Synthes (USA) Medial Distal Tibia Plates, (K001945) -Synthes Variable Angle Locking Compression Plate (VA-LCP), (K071184)…
Synthes (Usa)2000—
*K071184Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System
Summary page 8
…ynthes (USA) Medial Distal Tibia Plates, (K001945) -Synthes Variable Angle Locking Compression Plate (VA-LCP), (K071184) -Synthes One-Third Tubular DCL Plate, (K011335) -Synthes 4.5mm LCP Str…
Synthes (Usa)20071
*K011335Synths One-Third Tubular DCL Plate
Summary page 8
…-Synthes Variable Angle Locking Compression Plate (VA-LCP), (K071184) -Synthes One-Third Tubular DCL Plate, (K011335) -Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986) -Synthes…
Synthes (Usa)20012
*K051986Synthes 4.5 MM LCP Straight Reconstruction Plates
Summary page 8
…(K071184) -Synthes One-Third Tubular DCL Plate, (K011335) -Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986) -Synthes (USA) LCP Proxima Humerus Plates, Long, (K041860) Non-Clinical -Non-clini…
Synthes (Usa)2005—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 8
…-Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986) -Synthes (USA) LCP Proxima Humerus Plates, Long, (K041860) Non-Clinical -Non-clinical testing was performed in the subject devices as (Performance Testing): follows…
Synthes (Usa)2004—

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 24 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
  • 9 of the 37 ancestors have a recall of any class.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K201510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201510: Traufix osteosynthesis, osteotomy, and arthrodesis devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201510

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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