510(k) · Cleared
ClearedVersalock Periprosthetic Femur Plates System-GMReis
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 Mar 8, 2021 as substantially equivalent to K120772 (Zimmer GmbH, 2012) after a 258-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Mar 8, 2021
- Review
- 258 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981372 (1998). 24 ancestors in all, the oldest K953777 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 2 generations backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
- 1 generation backK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
- This deviceK201728 Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −2 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
| −1 | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB… | Zimmer GmbH | 2012 | 2 |
| 0 (this device) | K201728 | Versalock Periprosthetic Femur Plates System-GMReis | GM Dos Reis Industria e Comercio Ltda. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Summary page 5…Versalock Periprosthetic Femur Plates System - GMReis PREDICATE DEVICE INFORMATION Primary Predicate Device K120772 - NCB Periprosthetic Trochanter Plates and Screws and NCB Cable Button for NCB Polyaxi… | 2012 |
| † | K082527 | Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws | 2008 |
| † | K110354 | 4.5MM VA-LCP Curved Condylar Plate System | 2011 |
| † | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage… | 2015 |
| † | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking… | 2008 |
| † | K061211 | NCB Plating System, Proximal Tibia Plates | 2006 |
| † | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | 2016 |
| † | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | 2010 |
| † | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 |
| † | K042695 | NCB Plating System | 2004 |
| † | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle… | 2017 |
| † | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | 2019 |
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 23 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 4 other devices also cite its predicate K120772.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Periprosthetic Femur Plates System — GMReis is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:
* Periprosthetic fractures
» Comminuted fractures
* Supracondylar fractures
* Trochanteric fractures
* Fractures in normal and osteopenic bone
* Non-unions and Malunions.
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/K201728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201728: Versalock Periprosthetic Femur Plates System-GMReis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201728
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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