510(k) · Cleared

Cleared

ORTHOLOC® 3Di Small Bones Plating

K163039510(k) TraditionalCleared Mar 13, 2017133-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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on Mar 13, 2017 as substantially equivalent to K090692 (Wrightmedicaltechnologyinc, 2009) after a 133-day review. Its family tree reaches back 1 generation to 2009. 15 later devices descend from it.

Decided: Mar 13, 2017
Review: 133 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090692 (2009). 15 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK090692 Ortholoc 2.0/2.4 Plate SystemWrightmedicaltechnologyinc · 2009 · Recalled
This deviceK163039 ORTHOLOC® 3Di Small Bones PlatingWrightmedicaltechnologyinc · 2017
Descendant · cites it directly · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
Descendant · 2 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
Descendant · 2 generations on · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
Descendant · 3 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
Descendant · 2 generations on · 2 of its ownK233423 Tyber Medical Anatomical Plating System – Line extension to the…Tyber Medical, LLC · 2023

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2019high 5 (2023) · low 0 (2022)2026

Most influential descendants

Showing 5 of 15 · See all

K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · cites it directly10descendants
K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 2 generations on9descendants
K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · 2 generations on3descendants
K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 3 generations on2descendants
K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC · 2023 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090692	Ortholoc 2.0/2.4 Plate System	Wrightmedicaltechnologyinc	2009	1
0 (this device)	K163039	ORTHOLOC® 3Di Small Bones Plating	Wrightmedicaltechnologyinc	2017	—
+1	K203817	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2021	—
+2	K222465	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2023	—
+2	K232652	Anatomical Plating System (various)	Tyber Medical, LLC	2023	20
+3	K241218	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2024	—
+2	K233423	Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System	Tyber Medical, LLC	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	1	0
2021	2	0
2023	5	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K163039, 2009–2026Source: 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? (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	Applicant	Decided	Recalls
*	K090692	Ortholoc 2.0/2.4 Plate System Summary page 4 …21 CFR 888.3030 – Class II Device Product Code, Device Panel: HRS – Orthopedic (a)(3). Predicate Devices: Primary: K090692 - ORTHOLOC® 2.0/2.4 Reference: K152974 - Crosscheck Plates (a)(4). Devic…	Wrightmedicaltechnologyinc	2009	1
†	K152974	ORTHOLOC® 3Di Foot Plating Reconstruction System	Wrightmedicaltechnologyinc	2015	—

Also cleared against K090692: 9 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K203817	Tyber Medical Anatomical Plating System	Tyber Medical, LLC	2021	10
K190970	PROSTEP™ TBI™ (Tailors Bunion Implant) System	Wrightmedicaltechnologyinc	2019	1
K201259	ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System	Wrightmedicaltechnologyinc	2021	0
K191867	ATLAS Plating System	MiRus, LLC	2020	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?

Its one ancestor has a recall.
Of its descendants, K203817 (Tyber Medical, LLC, 2021) has gone furthest, with 10 descendants of its own.
9 other devices also cite its predicate K090692.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes. The system can be used in both adult and pediatric patients. Examples include:

- Metatarsal, metacarpal, or phalangeal fractures and osteotomies

- Lesser metatarsal shortening osteotomies (e.g. Weil)

- Fifth metatarsal fractures (e.g. Jones Fracture)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163039 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163039: ORTHOLOC® 3Di Small Bones Plating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163039

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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