510(k) · Cleared

Cleared

G3 Active Plate Large Fragment System

K142938510(k) TraditionalCleared Nov 26, 201448-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

Genesis Fracture Care, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 26, 2014 as substantially equivalent to K051986 (Synthes (Usa), 2005) and 5 other predicates after a 48-day review. Its family tree reaches back 10 generations to 1996. 3 later devices descend from it.

Decided: Nov 26, 2014
Review: 48 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 6

Its longest line of descent runs back 10 generations to K962616 (1996). 54 ancestors in all, the oldest K890939 (1989). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
6 generations between
3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
This deviceK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
Descendant · cites it directly · 2 of its ownK150649 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015
Descendant · cites it directly · 1 of its ownK152242 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 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 backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
This deviceK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all

K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015 · cites it directly2descendants
K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015 · cites it directly1descendant
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
−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	K061352	Peri-Loc Periarticular Locked Plating System for the Upper Extremity	Smith & Nephew, Inc.	2006	—
−2	K082516	Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws	Smith & Nephew, Inc.	2008	—
−1	K083032	Peri-Loc Bone Plating and Screw System	Smith & Nephew, Inc.	2009	2
0 (this device)	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	—
+1	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	5	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
2015	2	0
2016	1	0

FIG. 1 — Lineage of K142938, 1996–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K051986	Synthes 4.5 MM LCP Straight Reconstruction Plates Summary page 6 …to the following plate and screw systems previously cleared by the FDA: - Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005) - Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669,…	Synthes (Usa)	2005	—
*	K033669	Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) Summary page 6 …- Synthes 4.5mm LCP Reconstruction Plates (K051986, S.E. 09/08/2005) - Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669, S.E. 12/10/2003 and K083032, S.E. 01/07/2009) - Zimmer MotionLo…	Smith & Nephew, Inc.	2003	1
*	K083032	Peri-Loc Bone Plating and Screw System Summary page 6 …, S.E. 09/08/2005) - Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669, S.E. 12/10/2003 and K083032, S.E. 01/07/2009) - Zimmer MotionLoc™ Screws for NCB® Locking Plate system (K042695;…	Smith & Nephew, Inc.	2009	2
*	K042695	NCB Plating System Summary page 6 …S.E. 12/10/2003 and K083032, S.E. 01/07/2009) - Zimmer MotionLoc™ Screws for NCB® Locking Plate system (K042695; S.E.10/29/2004 and K101696; S.E. 09/10/2010) - Zimmer Periartic…	Zimmer GmbH	2004	1
*	K101696	Motionloc Screw for NCB Polyaxial Locking Plating System Summary page 6 …, S.E. 01/07/2009) - Zimmer MotionLoc™ Screws for NCB® Locking Plate system (K042695; S.E.10/29/2004 and K101696; S.E. 09/10/2010) - Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004)…	Zimmer, Inc.	2010	—
*	K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series Summary page 6 …stem (K042695; S.E.10/29/2004 and K101696; S.E. 09/10/2010) - Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004) Additionally, Medisil Silicone Sheeting (K040042; S.E. 4/1/2004) was provided…	Zimmer, Inc.	2004	2
†	K040042	Medisil Silicone Sheeting	Medisil Corporation	2004	—

Also cleared against K051986: 11 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150649	G3 Active Plate Large Fragment System	Genesis Fracture Care, Inc.	2015	2
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	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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
16 of the 54 ancestors have a recall of any class.
Of its descendants, K150649 (Genesis Fracture Care, Inc., 2015) has gone furthest, with 2 descendants of its own.
11 other devices also cite its predicate K051986.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

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

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

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 system is intended for use in adult and pediatric cases (subpopulation: transitional adolescent B (18 years to <21 years) requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open 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/K142938 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142938: 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/K142938

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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