510(k) · Cleared
ClearedG3¿ Active Plate® Large Fragment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Fracture Care, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 24, 2015 as substantially equivalent to K142938 (Genesis Fracture Care, Inc., 2014) and 4 other predicates after a 106-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Nov 24, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K962616 (1996). 58 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 2 generations backK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
- 1 generation backK150649 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015
- This deviceK152242 G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK160633 G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 4 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 2 generations backK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
- 1 generation backK150649 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015
- This deviceK152242 G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −4 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −3 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −2 | K142938 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2014 | — |
| −1 | K150649 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2015 | — |
| 0 (this device) | K152242 | G3¿ Active Plate® Large Fragment System | Genesis Fracture Care, Inc. | 2015 | — |
| +1 | K160633 | G3(TM) Active Plate (R) Small Fragment System | Genesis Fracture Care, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K142938 | G3 Active Plate Large Fragment SystemSummary page 5…ially equivalent to the following plate and screw systems previously cleared by the FDA: Primary Predicate o G3™ Active Plate Large Fragment System (K142938, S.E. 11/26/2014 & K150649, S.E. 04/30/2015) Predicates: o Synthes 4.5mm LCP Reconstruction P… | 2014 |
| * | K150649 | G3 Active Plate Large Fragment SystemSummary page 5…lowing plate and screw systems previously cleared by the FDA: Primary Predicate o G3™ Active Plate Large Fragment System (K142938, S.E. 11/26/2014 & K150649, S.E. 04/30/2015) Predicates: o Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/… | 2015 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 5…te Large Fragment System (K142938, S.E. 11/26/2014 & K150649, S.E. 04/30/2015) Predicates: o Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005) o Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004 & K042598, S.E.… | 2005 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 5…04/30/2015) Predicates: o Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005) o Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004 & K042598, S.E. 10/29/2004) Reference Devices: o Smith & Nephew Ilizarov Ext… | 2004 |
| * | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 SeriesSummary page 5…tes: o Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005) o Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004 & K042598, S.E. 10/29/2004) Reference Devices: o Smith & Nephew Ilizarov External Fixation System (K962… | 2004 |
| † | K962808 | Ilizarov External Fixation System | 1996 |
| † | K955848 | Orthofix Modulsystem | 1996 |
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 |
|---|---|---|---|
| K160633 | G3(TM) Active Plate (R) Small Fragment System | 2016 | 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 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 17 of the 58 ancestors have a recall of any class.
- Of its descendants, K160633 (Genesis Fracture Care, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142938.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152242: G3¿ Active Plate® Large Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152242
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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