510(k) · Cleared

Cleared

PROstep (TM) MIS 5mm Chamfer Screw System

K221645510(k) AbbreviatedCleared Feb 17, 2023256-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

Wright Medical Technology · HWC Screw, Fixation, Bone

Cleared on Feb 17, 2023 as substantially equivalent to K162353 (Wrightmedicaltechnologyinc, 2017) after a 256-day review. Its family tree reaches back 2 generations to 2008.

Decided: Feb 17, 2023
Review: 256 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K082320 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
1 generation backK162353 MICATM Screw SystemWrightmedicaltechnologyinc · 2017
This deviceK221645 PROstep (TM) MIS 5mm Chamfer Screw SystemWright Medical Technology · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K082320	Darco Small Screw	Wrightmedicaltechnologyinc	2008	—
−1	K162353	MICATM Screw System	Wrightmedicaltechnologyinc	2017	—
0 (this device)	K221645	PROstep (TM) MIS 5mm Chamfer Screw System	Wright Medical Technology	2023	—

FIG. 1 — Lineage of K221645, 2008–2023Source: 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
*	K162353	MICATM Screw System Summary page 4 ….3040 – Class II Product Code – Device Panel: HWC – Orthopedic Device Class: Class II Primary Predicate: K162353: PROstep TM MICATM Screw System Additional Predicates: N/A Reference Device: K203228:…	Wrightmedicaltechnologyinc	2017	—
†	K203228	DART-FIRE EDGE Cannulated Screw System	Wright Medical	2021	—

Also cleared against K162353: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
None of the 2 ancestors has a recall.
8 other devices also cite its predicate K162353.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 PROstep™ MIS 5mm Chamfer Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

- Arthrodesis of the first metatarsal cuneiform joint to reposition and stabilize metatarsus primus varus

- Calcaneus/cuboid arthrodesis

- Talar/navicular arthrodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221645 · printed Nov 4, 2026

Cite this page

510(k) Report. “K221645: PROstep (TM) MIS 5mm Chamfer Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221645

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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