510(k) Report

510(k) · Cleared

Cleared

Versalock Sterile Plating System

K262537510(k) SpecialCleared Aug 19, 202627-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 Aug 19, 2026 as substantially equivalent to K260390 (GM Dos Reis Industria e Comercio Ltda., 2026) and 5 other predicates after a 27-day review. Its family tree reaches back 13 generations to 1996.

Decided
Aug 19, 2026
Review
27 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
6

Its longest line of descent runs back 13 generations to K962616 (1996). 207 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2026: 1 other ancestor2025: 1 other ancestor2024: 1 other ancestor2020: 1 other ancestor2017: 1 other ancestor2015: 1 other ancestor2014: 2 other ancestors2013: 1 other ancestor2011: 5 other ancestors2008: 8 other ancestors2005: 13 other ancestors2004: 12 other ancestors2000: 12 other ancestors1995: 8 other ancestors2012: 1 other ancestor2010: 5 other ancestors2009: 12 other ancestors2007: 7 other ancestors2006: 8 other ancestors2001: 15 other ancestors1996: 17 other ancestors2003: 11 other ancestors2002: 9 other ancestors1999: 7 other ancestors1998: 8 other ancestors1997: 6 other ancestors1994: 7 other ancestors1992: 2 other ancestors1991: 2 other ancestors1990: 3 other ancestors1989: 2 other ancestors1993: 3 other ancestors1988: 1 other ancestor1979: 1 other ancestorK962616 · 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. · 2024K260390 · Super Upper Limbs Versalock Plating System · GM Dos Reis Industria e Comercio Ltda. · 202619801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 12 other ancestors3 generations back: 30 other ancestors4 generations back: 59 other ancestors5 generations back: 41 other ancestors6 generations back: 31 other ancestors7 generations back: 12 other ancestors8 generations back: 6 other ancestors K260390 · Super Upper Limbs Versalock Plating System · GM Dos Reis Industria e Comercio Ltda. · 2026K242596 · 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 · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations between
  3. 3 generations backK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  4. 2 generations backK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  5. 1 generation backK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  6. This deviceK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Show all 13 generations
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 3 generations backK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  12. 2 generations backK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  13. 1 generation backK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  14. This deviceK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−12K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−11K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−10K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−7K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−6K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−5K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—
−2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.2024—
−1K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026—
0 (this device)K262537Versalock 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
2005130
200680
200770
200880
2009120
201050
201150
201210
201310
201420
201510
201710
202010
202410
202510
202610
FIG. 1 — Lineage of K262537, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*K260390Super Upper Limbs Versalock Plating System
Summary page 5
…mber: 21 CFR 888.3030 / 21 CFR 888.3040 III. Predicate Devices: Legally marketed device to which we are claiming “Substantial Equivalence” are the following: K260390 - Super Upper Limbs Versalock Plating System (Primary Predicate Device) K242596 - Versalock Mini and Micro Plating System (Additi…
GM Dos Reis Industria e Comercio Ltda.2026—
*K242596Versalock Mini and Micro Plating System
Summary page 5
…lly marketed device to which we are claiming “Substantial Equivalence” are the following: K260390 - Super Upper Limbs Versalock Plating System (Primary Predicate Device) K242596 - Versalock Mini and Micro Plating System (Additional Predicate Device) K242998 - GMReis Ankle Plating System (Additional Predica…
GM Dos Reis Industria e Comercio Ltda.2024—
*K242998GMReis Ankle Plating System
Summary page 5
…ollowing: K260390 - Super Upper Limbs Versalock Plating System (Primary Predicate Device) K242596 - Versalock Mini and Micro Plating System (Additional Predicate Device) K242998 - GMReis Ankle Plating System (Additional Predicate Device) K243740 - Versalock Upper Limb Plating System (Additional Predicate D…
GM Dos Reis Industria e Comercio Ltda.2024—
*K243740Versalock Upper Limb Plating System
Summary page 5
…ary Predicate Device) K242596 - Versalock Mini and Micro Plating System (Additional Predicate Device) K242998 - GMReis Ankle Plating System (Additional Predicate Device) K243740 - Versalock Upper Limb Plating System (Additional Predicate Device) K182718 - Mini and Micro Fragments Reconstruction System – GM…
GM Dos Reis Industria e Comercio Ltda.2025—
*K182718Mini and Micro Fragments Reconstruction System – GMReis
Summary page 5
…itional Predicate Device) K242998 - GMReis Ankle Plating System (Additional Predicate Device) K243740 - Versalock Upper Limb Plating System (Additional Predicate Device) K182718 - Mini and Micro Fragments Reconstruction System – GMReis (Additional Predicate Device) K261406 - Versalock Proximal Tibial Plati…
Gm Dos Reis Industria E Comerico Ltda.2019—
*K261406Versalock Proximal Tibial Plating System
Summary page 5
…43740 - Versalock Upper Limb Plating System (Additional Predicate Device) K182718 - Mini and Micro Fragments Reconstruction System – GMReis (Additional Predicate Device) K261406 - Versalock Proximal Tibial Plating System (Additional Predicate Device) GM dos Reis Industria e Comercio Ltda. Pierre Simon…
GM Dos Reis Industria e Comercio Ltda.2026—

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 30 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 43 of the 207 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. 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 Versalock Sterile Plating System is intended for fracture fixation, arthrodesis, reconstruction, osteotomy, fixation and non-unions of the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

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

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
  • K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K260390Super Upper Limbs Versalock 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/K262537 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262537: Versalock Sterile 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/K262537

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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