510(k) · Cleared

Cleared

Orthopediatrics Plating System

K073344510(k) TraditionalCleared Feb 19, 200883-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

Orthopediatrics, LLC · HRS Plate, Fixation, Bone

Cleared on Feb 19, 2008 as substantially equivalent to K002486 (Patrick Berdoz, 2000) and 2 other predicates after an 83-day review. Its family tree reaches back 1 generation to 1999. 66 later devices descend from it.

Decided: Feb 19, 2008
Review: 83 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K993106 (1999). 3 ancestors in all. 66 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
This deviceK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
Descendant · cites it directly · 65 of its ownK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
Descendant · cites it directly · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
Descendant · 2 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
Descendant · cites it directly · 15 of its ownK090666 PediplatesOrthoPediatrics Corp. · 2009
Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2008high 10 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 66 · See all

K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008 · cites it directly65descendants
K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · cites it directly60descendants
K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 2 generations on28descendants
K090666PediplatesOrthoPediatrics Corp. · 2009 · cites it directly15descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993106	Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)	Smith & Nephew, Inc.	1999	—
0 (this device)	K073344	Orthopediatrics Plating System	Orthopediatrics, LLC	2008	—
+1	K081407	Orthopediatrics Pediplates System	OrthoPediatrics Corp.	2008	—
+1	K083286	Orthopediatrics Pediloc Locking Plate System	OrthoPediatrics Corp.	2009	5
+2	K120689	Synthes 3.5 MM VA-LCP Proximal Tibia Plate System	Synthes (USA) Products, LLC	2012	—
+1	K090666	Pediplates	OrthoPediatrics Corp.	2009	—
+2	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	3	0
2010	2	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2017	6	0
2018	3	0
2019	5	0
2020	6	0
2021	1	0
2022	4	0
2023	5	0
2024	10	0
2025	8	0
2026	6	0

FIG. 1 — Lineage of K073344, 1999–2026Source: 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? (3)

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
*	K002486	Precimed Trauma System Summary page 1 …er 21 CFR §888.3030 DEVICE PRODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: Precimed Trauma System (K002486) Precimed Cannulated Screw System (K050754) Smith & Nephew Bone Pla…	Patrick Berdoz	2000	—
*	K050754	Precimed Cannulated Screw System Summary page 1 …: HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: Precimed Trauma System (K002486) Precimed Cannulated Screw System (K050754) Smith & Nephew Bone Plate System (TC-100 Plating and Screw System)…	Precimed, Inc.	2005	—
*	K993106	Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) Summary page 1 …cimed Cannulated Screw System (K050754) Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) (K993106) DEVICE DESCRIPTION: The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric…	Smith & Nephew, Inc.	1999	—

What descends from it? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K081407	Orthopediatrics Pediplates System	OrthoPediatrics Corp.	2008	65
K083286	Orthopediatrics Pediloc Locking Plate System	OrthoPediatrics Corp.	2009	60
K090666	Pediplates	OrthoPediatrics Corp.	2009	15

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?

None of the 3 ancestors has a recall.
Of its descendants, K081407 (OrthoPediatrics Corp., 2008) has gone furthest, with 65 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OrthoPediatrics Plating System is intended for use in the treatment of pelvic,

small and long bone fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073344: Orthopediatrics 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/K073344

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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