510(k) · Cleared
ClearedMini and Micro Fragments Reconstruction System – GMReis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gm Dos Reis Industria E Comerico Ltda. · HRS Plate, Fixation, Bone
Cleared on Dec 23, 2019 as substantially equivalent to K142419 (Neoortho Productos Orthopedicos S/A, 2014) and 4 other predicates after a 451-day review. Its family tree reaches back 10 generations to 1996. 4 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 451 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962616 (1996). 133 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
- Descendant · cites it directly · 2 of its ownK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
- Descendant · cites it directly · 1 of its ownK260390 Super Upper Limbs Versalock 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
- Descendant · cites it directly · 0 of its ownK231684 Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda. · 2024
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
Most influential descendants
Showing 4 of 4 · See all- K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · cites it directly2descendants
- K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly1descendant
- K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly0descendants
- K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019 | — |
| +1 | K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
| +1 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +1 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +1 | K231684 | Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 12 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 11 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIXSummary page 4…n Regulations 21 CFR 888.3030, Class II Review Panel Orthopedic PREDICATE DEVICE INFORMATION Predicate Devices K142419 - NEOORTHO Produtos Ortopédicos S/A - Neoortho Productos Orthopedicos S/A (Primary Predicate)… | 2014 |
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 4…K142419 - NEOORTHO Produtos Ortopédicos S/A - Neoortho Productos Orthopedicos S/A (Primary Predicate) K051567 – APTUS® Titanium Fixation System - Medartis, Inc. K100776 - Synthes 2.4mm12.7 mm Variable Angle… | 2005 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 4…Productos Orthopedicos S/A (Primary Predicate) K051567 – APTUS® Titanium Fixation System - Medartis, Inc. K100776 - Synthes 2.4mm12.7 mm Variable Angle LCP forefoot/. Midfoot system - Synthes (USA) LP… | 2010 |
| * | K081546 | Small Bone Locking Plating SystemSummary page 4…K100776 - Synthes 2.4mm12.7 mm Variable Angle LCP forefoot/. Midfoot system - Synthes (USA) LP K081546 - Small Bone Locking Plating System – DePuy Orthopaedics, Inc. K1… | 2008 |
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 4…LP K081546 - Small Bone Locking Plating System – DePuy Orthopaedics, Inc. K142906 - APTUS® Wrist 2.5 System – Medartis AG Reference Device K180626 – Pedimax II -Pedicular Screw Spinal System - GM… | 2015 |
| † | K180626 | Pedimax II - Pedicular Screw Spinal System | 2019 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 36 of the 133 ancestors have a recall of any class.
- Of its descendants, K242596 (GM Dos Reis Industria e Comercio Ltda., 2024) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K142419.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. 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.
https://510kreport.com/device/K182718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182718: Mini and Micro Fragments Reconstruction System – GMReis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182718
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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