510(k) · Cleared

Cleared

MICATM Screw System

K162353510(k) TraditionalCleared Apr 13, 2017233-day reviewClass II21 CFR 888.3040

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

Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone

Cleared on Apr 13, 2017 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) after a 233-day review. Its family tree reaches back 1 generation to 2008. 33 later devices descend from it.

Decided: Apr 13, 2017
Review: 233 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082320 (2008). 33 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
This deviceK162353 MICATM Screw SystemWrightmedicaltechnologyinc · 2017
Descendant · cites it directly · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
Descendant · 2 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
Descendant · 3 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
Descendant · 2 generations on · 6 of its ownK203011 Monster Screw SystemParagon 28, Inc. · 2020
Descendant · 3 generations on · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2019high 10 (2023) · low 2 (2021)2026

Most influential descendants

Showing 5 of 33 · See all

K190586Monster® Screw SystemParagon 28, Inc. · 2019 · cites it directly21descendants
K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 2 generations on9descendants
K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 3 generations on8descendants
K203011Monster Screw SystemParagon 28, Inc. · 2020 · 2 generations on6descendants
K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082320	Darco Small Screw	Wrightmedicaltechnologyinc	2008	—
0 (this device)	K162353	MICATM Screw System	Wrightmedicaltechnologyinc	2017	—
+1	K190586	Monster® Screw System	Paragon 28, Inc.	2019	—
+2	K200398	AxSOS 3 AF System and AxSOS 3 Ti System	Stryker GmbH	2020	—
+3	K222381	PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…	Stryker GmbH	2023	—
+2	K203011	Monster Screw System	Paragon 28, Inc.	2020	—
+3	K231262	Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia…	Stryker GmbH	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	4	0
2020	3	0
2021	2	0
2022	3	0
2023	10	0
2024	2	0
2025	2	0
2026	7	0

FIG. 1 — Lineage of K162353, 2008–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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
*	K082320	Darco Small Screw Summary page 4 …metallic bone fixation fastener Device Product Code, Device Panel: HWC - Orthopedic 3. Predicate Device: K082320- WrightTM Compression Screw 4. Device Description The MICATM Screws are intended for use in bone reconstruction,…	Wrightmedicaltechnologyinc	2008	—

Also cleared against K082320: 17 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K190586	Monster® Screw System	Paragon 28, Inc.	2019	21
K192356	Airlock Centrolock Osteosynthesis Implant System	Novastep	2019	2
K231236	IBS-B MIS Beveled Screw System	In2bones USA, LLC	2023	1
K223392	REVCON (TM) Screw System	Voom Medical Devices, Inc.	2023	0
K221645	PROstep (TM) MIS 5mm Chamfer Screw System	Wright Medical Technology	2023	0
K221090	Metal Cannulated Screw	Double Medical Technology, Inc.	2023	0
K210994	Arthrex Beveled FT Screws	Arthrex, Inc.	2021	0
K183620	PROSTEP TBC Implant System	Wrightmedicaltechnologyinc	2019	0
K181377	PROSTEP MICA Screw System	Wrightmedicaltechnologyinc	2019	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 no recall.
Of its descendants, K190586 (Paragon 28, Inc., 2019) has gone furthest, with 21 descendants of its own.
17 other devices also cite its predicate K082320.

How does its category compare?

All HWC devices

HWC Screw, 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 · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

* Mono or Bi-Cortical osteotomies in the foot or hand

* Distal or Proximal metatarsal or metacarpal osteotomies

* Weil osteotomy

* Fusion of the first metatarsophalangeal joint and interphalangeal joint

* Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

Akin type osteotomy

* Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus

* Calcaneus/cuboid arthrodesis

* Talar/navicular arthrodesis

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K162353 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162353: MICATM Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162353

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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