510(k) · Cleared

Recalled · Class II · 2021

Anthrex Titanium Opening Wedge Osteotomy System

K032187510(k) TraditionalCleared Sep 22, 200367-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 22, 2003 after a 67-day review. The FDA summary names no predicate by number. 37 later devices descend from it. It has been recalled once.

Decided: Sep 22, 2003
Review: 67 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 0

37 later devices descend from it, 3 citing it directly.

This deviceK032187 Anthrex Titanium Opening Wedge Osteotomy SystemArthrex, Inc. · 2003
Descendant · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
Descendant · 2 generations on · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
Descendant · 3 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
Descendant · 2 generations on · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
Descendant · 4 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2009high 5 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 37 · See all

K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · 2 generations on9descendants
K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on8descendants
K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · 2 generations on8descendants
K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032187	Anthrex Titanium Opening Wedge Osteotomy System	Arthrex, Inc.	2003	—
+1	K140397	Paralock Plating System / Tuffnek Screw	Paragon 28	2014	—
+2	K170693	Phantom Small Bone Intramedullary Nail System	Paragon 28, Inc.	2017	—
+3	K182307	Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…	Paragon 28, Inc.	2019	—
+2	K170214	Additive Orthopaedics Locking Lattice Plate	Additive Orthopaedics, LLC	2017	—
+4	K192163	TTC Phantom® Intramedullary Nail System	Paragon 28, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2015	1	0
2017	5	0
2018	3	0
2019	4	0
2020	5	0
2021	5	0
2022	1	0
2023	4	0
2024	4	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K032187, 2003–2026Source: 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

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K140397	Paralock Plating System / Tuffnek Screw	Paragon 28	2014	31
K141548	High Tibial Osteotomy System	Newclip Technics	2015	3
K092381	Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor…	Ibalance Medical, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 11, 2021	Class II	Z-1380-2021	Under Investigation by firm	It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K140397 (Paragon 28, 2014) has gone furthest, with 31 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.

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 Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies. The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required. Specifically for use in treatment of non-union, malunion, and fractures of proximal…

Read the full statement (100 words)

The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.

The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required.

Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia and distal femur including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

It is intended to be used with adequate post-operative immobilization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032187 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032187: Anthrex Titanium Opening Wedge Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032187

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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