510(k) · Cleared
ClearedVersalock Proximal Tibial Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GM Dos Reis Industria e Comercio Ltda. · HRS Plate, Fixation, Bone
Cleared on Jul 21, 2026 as substantially equivalent to K112437 (Arthrex, Inc., 2011) and 1 other predicate after an 83-day review. Its family tree reaches back 9 generations to 2000. 1 later device descends from it.
- Decided
- Jul 21, 2026
- Review
- 83 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K000684 (2000). 76 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations between
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- This deviceK261406 Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · cites it directly · 0 of its ownK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Show all 9 generations
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- This deviceK261406 Versalock Proximal Tibial 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −8 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −7 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −6 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −5 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −4 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −3 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −2 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −1 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +1 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K112437 | Arthrex Fracture SystemSummary page 5…21 CFR 888.3030/888.3040 III. Predicate Devices: Legally marketed device to which we are claiming “Substantial Equivalence” are the following: Arthrex Fracture System (K112437) (Primary Predicate Device) Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Reference Device) AOS Fibonacci Lo… | 2011 |
| * | K202489 | AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemSummary page 5…e) Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Reference Device) AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489) (Additional Predicate Device) Versalock Upper Limb Plating System (K243740) (Reference Device) GM dos Reis Industria e Comer… | 2020 |
| † | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | 2019 |
| † | K243740 | Versalock Upper Limb Plating System | 2025 |
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 |
|---|---|---|---|
| K262537 | Versalock Sterile Plating System | 2026 | 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 26 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 76 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.
- 5 other devices also cite its predicate K112437.
How does its category compare?
All HRS devicesHRS 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
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 Versalock Proximal Tibial Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the proximal tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261406: Versalock Proximal Tibial Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261406
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026