510(k) · Cleared

Cleared

Charlotte Carolina Jones Fracture System Screw

K140952510(k) SpecialCleared May 15, 201431-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 May 15, 2014 as substantially equivalent to K053136 (Wrightmedicaltechnologyinc, 2006) after a 31-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.

Decided: May 15, 2014
Review: 31 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K053136 (2006). 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK053136 5TH Metatarsal Fracture ScrewWrightmedicaltechnologyinc · 2006
This deviceK140952 Charlotte Carolina Jones Fracture System ScrewWrightmedicaltechnologyinc · 2014
Descendant · cites it directly · 2 of its ownK191289 Bone Screw Line AdditionVilex IN Tennessee, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
Descendant · cites it directly · 1 of its ownK183026 Wright Jones Fracture SystemWrightmedicaltechnologyinc · 2019
Descendant · 3 generations on · 0 of its ownK230946 Accelerate Compression Screw System-Small Product Code ACC-S…Trax Surgical · 2023
Descendant · 2 generations on · 0 of its ownK201319 Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc. · 2020

Most influential descendants

Showing 5 of 5 · See all

K191289Bone Screw Line AdditionVilex IN Tennessee, Inc. · 2019 · cites it directly2descendants
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020 · 2 generations on1descendant
K183026Wright Jones Fracture SystemWrightmedicaltechnologyinc · 2019 · cites it directly1descendant
K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical · 2023 · 3 generations on0descendants
K201319Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc. · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K053136	5TH Metatarsal Fracture Screw	Wrightmedicaltechnologyinc	2006	—
0 (this device)	K140952	Charlotte Carolina Jones Fracture System Screw	Wrightmedicaltechnologyinc	2014	—
+1	K191289	Bone Screw Line Addition	Vilex IN Tennessee, Inc.	2019	—
+2	K202817	GEO Bone Screw System	Gramercy Extremity Orthopedics, LLC	2020	—
+1	K183026	Wright Jones Fracture System	Wrightmedicaltechnologyinc	2019	—
+3	K230946	Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate…	Trax Surgical	2023	—
+2	K201319	Medline UNITE Jones Fracture Screw System	Medline Industires, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2020	2	0
2023	1	0

FIG. 1 — Lineage of K140952, 2006–2023Source: 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

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
*	K053136	5TH Metatarsal Fracture Screw Summary page 1 …21 CFR 888.3040- Class 11 Device Product Code, Device Panel: HWC - Orthopedic 3. Predicate Device: K053 136 5Ih Metatarsal Fracture Screw 4. Device Description The CHARLOTTE""M CAROLINA"" Jones Fracture System screw is a c…	Wrightmedicaltechnologyinc	2006	—

Also cleared against K053136: 3 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K191289	Bone Screw Line Addition	Vilex IN Tennessee, Inc.	2019	2
K183026	Wright Jones Fracture System	Wrightmedicaltechnologyinc	2019	1

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, K191289 (Vilex IN Tennessee, Inc., 2019) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K053136.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CHARLOTTE™ CAROLINA™ Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:

Fixation of malunions and nonunions

Acute fractures

Avulsion fractures

Repetitive stress fractures

Jones Fractures

Malleolar Fractures

Talus Fractures

Greater Tuberosity Fractures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140952 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140952: Charlotte Carolina Jones Fracture System Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140952

Report an extraction error

Are you the manufacturer?

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