510(k) Report

510(k) · Cleared

Cleared

Super Upper Limbs Versalock Plating System

K260390510(k) TraditionalCleared Mar 17, 202639-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

GM Dos Reis Industria e Comercio Ltda. · HRS Plate, Fixation, Bone

Cleared on Mar 17, 2026 as substantially equivalent to K182718 (Gm Dos Reis Industria E Comerico Ltda., 2019) and 8 other predicates after a 39-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.

Decided
Mar 17, 2026
Review
39 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
9

Its longest line of descent runs back 12 generations to K962616 (1996). 200 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2015: 1 other ancestor2014: 2 other ancestors2013: 1 other ancestor2000: 12 other ancestors1995: 8 other ancestors2012: 1 other ancestor2011: 5 other ancestors2010: 5 other ancestors2009: 12 other ancestors2008: 7 other ancestors2007: 7 other ancestors2006: 8 other ancestors2005: 12 other ancestors2004: 12 other ancestors2001: 15 other ancestors2003: 11 other ancestors2002: 9 other ancestors1998: 8 other ancestors1997: 6 other ancestors1996: 17 other ancestors1999: 7 other ancestors1991: 2 other ancestors1989: 2 other ancestors1994: 7 other ancestors1992: 2 other ancestors1990: 3 other ancestors1988: 1 other ancestor1993: 3 other ancestors1979: 1 other ancestor2026: 1 descendant clearedReference device: K232829 · Versalock Rib and Sternum Plates System · GM Dos Reis Industria e Comercio Ltda. · 2024K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K182718 · Mini and Micro Fragments Reconstruction System – GMReis · Gm Dos Reis Industria E Comerico Ltda. · 2019K242596 · Versalock Mini and Micro Plating System · GM Dos Reis Industria e Comercio Ltda. · 202419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 21 other ancestors3 generations back: 50 other ancestors4 generations back: 39 other ancestors5 generations back: 28 other ancestors6 generations back: 26 other ancestors7 generations back: 11 other ancestors8 generations back: 6 other ancestors 1 generation forward: 1 descendant K242596 · Versalock Mini and Micro Plating System · GM Dos Reis Industria e Comercio Ltda. · 2024K182718 · Mini and Micro Fragments Reconstruction System – GMReis · Gm Dos Reis Industria E Comerico Ltda. · 2019K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. 2 generations backK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  5. 1 generation backK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  6. This deviceK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  7. Descendant · cites it directly · 0 of its ownK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 2 generations backK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  12. 1 generation backK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  13. This deviceK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—
−1K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.2024—
0 (this device)K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026—
+1K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198810
198920
199030
199120
199220
199330
199470
199580
1996170
199760
199880
199970
2000120
2001150
200290
2003110
2004120
2005120
200680
200770
200870
2009120
201050
201150
201210
201310
201420
201510
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K260390, 1996–2026Source: 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
Get a 510(k) Report

What was it cleared against? (9)

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
*K182718Mini and Micro Fragments Reconstruction System – GMReis
Summary page 5
…Predicate Devices: Legally marketed device to which we are claiming “Substantial Equivalence” are the following: Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Primary Predicate Device) Versalock Mini and Micro Plating System (K242596) (Additional Predicate Device) APTUS® Wrist 2.5 Syst…
Gm Dos Reis Industria E Comerico Ltda.2019—
*K242596Versalock Mini and Micro Plating System
Summary page 5
…ial Equivalence” are the following: Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Primary Predicate Device) Versalock Mini and Micro Plating System (K242596) (Additional Predicate Device) APTUS® Wrist 2.5 System (K142906) (Additional Predicate Device) Fracture Plates (K123241) (Additio…
GM Dos Reis Industria e Comercio Ltda.2024—
*K142906APTUS Wrist 2.5 System
Summary page 5
…onstruction System - GMReis (K182718) (Primary Predicate Device) Versalock Mini and Micro Plating System (K242596) (Additional Predicate Device) APTUS® Wrist 2.5 System (K142906) (Additional Predicate Device) Fracture Plates (K123241) (Additional Predicate Device) APTUS® Wrist 2.5 System (K172170) (Additio…
Medartis AG2015—
*K123241Arthrex Fracture Plates
Summary page 5
…Device) Versalock Mini and Micro Plating System (K242596) (Additional Predicate Device) APTUS® Wrist 2.5 System (K142906) (Additional Predicate Device) Fracture Plates (K123241) (Additional Predicate Device) APTUS® Wrist 2.5 System (K172170) (Additional Predicate Device) Mini and Micro Fragments Reconstru…
Arthrex, Inc.2013—
*K172170APTUS (R) Wrist 2.5 System
Summary page 5
…tional Predicate Device) APTUS® Wrist 2.5 System (K142906) (Additional Predicate Device) Fracture Plates (K123241) (Additional Predicate Device) APTUS® Wrist 2.5 System (K172170) (Additional Predicate Device) Mini and Micro Fragments Reconstruction System-Neofix (K142419) (Additional Predicate Device) Synt…
Medartis AG2017—
*K142419Mini and Micro Fragments Reconstruction System-NEOFIX
Summary page 5
…ure Plates (K123241) (Additional Predicate Device) APTUS® Wrist 2.5 System (K172170) (Additional Predicate Device) Mini and Micro Fragments Reconstruction System-Neofix (K142419) (Additional Predicate Device) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) (Additional Predicate De…
Neoortho Productos Orthopedicos S/A2014—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 5
…te Device) Mini and Micro Fragments Reconstruction System-Neofix (K142419) (Additional Predicate Device) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) (Additional Predicate Device) GM dos Reis Industria e Comercio Ltda. Pierre Simon de Laplace Ave., 600, Block 3F9677 Techno Par…
Synthes (Usa)20001
*K141232Aptus Ulna Shortening 2.5
Summary page 6
…remarket Notification 510(k) - FDA Page 2 of 3 APTUS® Ulna Shortening 2.5 (K141232) (Additional Predicate Device) Small Fragment Plates and Screws (K951302) (Additional Predicate Device) Versalock Rib and Sternum…
Medartis AG20141
*K951302Small Fragment Plates and Screws
Summary page 6
…Page 2 of 3 APTUS® Ulna Shortening 2.5 (K141232) (Additional Predicate Device) Small Fragment Plates and Screws (K951302) (Additional Predicate Device) Versalock Rib and Sternum Plates System (K232829) (Reference Device) IV. Device Description: The…
Medpac19951
†K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.2024—

Also cleared against K182718: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260

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 30 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 43 of the 200 ancestors have a recall of any class.
  • Of its descendants, K262537 (GM Dos Reis Industria e Comercio Ltda., 2026) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K182718.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?

The Super Upper Limbs Versalock Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand, wrist and forearm. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Indications for use as stated in the FDA summary.

Also cleared against K182718

3 other devices cite the same predicate.

  • K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  • K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda. · 2024

More from GM Dos Reis Industria e Comercio Ltda.

16 FDA decisions under this applicant name. See the company

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
  • K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025

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/K260390 · printed Nov 4, 2026

Cite this page

510(k) Report. “K260390: Super Upper Limbs Versalock Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260390

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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