510(k) · Cleared

Cleared

Charlotte Compression Plate

K051908510(k) SpecialCleared Aug 10, 200527-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 Aug 10, 2005 as substantially equivalent to K043059 (Wrightmedicaltechnologyinc, 2005) after a 27-day review. Its family tree reaches back 1 generation to 2005. 149 later devices descend from it.

Decided: Aug 10, 2005
Review: 27 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K043059 (2005). 149 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK043059 Compression Staple and Simple StapleWrightmedicaltechnologyinc · 2005
This deviceK051908 Charlotte Compression PlateWrightmedicaltechnologyinc · 2005
Descendant · cites it directly · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
Descendant · 2 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
Descendant · 2 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
Descendant · cites it directly · 53 of its ownK092528 Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp) · 2010

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

2007high 17 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 149 · See all

K070447Newdeal Compression PlateNewdeal Sas · 2007 · cites it directly102descendants
K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 2 generations on98descendants
K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 2 generations on95descendants
K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp) · 2010 · cites it directly53descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K043059	Compression Staple and Simple Staple	Wrightmedicaltechnologyinc	2005	—
0 (this device)	K051908	Charlotte Compression Plate	Wrightmedicaltechnologyinc	2005	—
+1	K070447	Newdeal Compression Plate	Newdeal Sas	2007	2
+2	K093914	Newdeal Compression Plates	Newdeal Sas	2011	5
+1	K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	12
+2	K121651	Ortholoc 3DI Midfoot/Flatfoot System	Wrightmedicaltechnologyinc	2012	—
+1	K092528	Biomet Forerunner Locking Plate System	Biomet Trauma (Aka Ebi, Lp)	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2012	6	0
2013	1	0
2014	8	0
2015	9	0
2016	8	0
2017	14	0
2018	7	0
2019	7	0
2020	17	0
2021	9	0
2022	9	0
2023	15	0
2024	15	0
2025	10	0
2026	10	0

FIG. 1 — Lineage of K051908, 2005–2026Source: 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? (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
*	K043059	Compression Staple and Simple Staple Summary page 1 …ations for use of the CHARLOTTETM Compression Plate are substantially equivalent or identical to the previously cleared Compression Staple (K043059). The safety and effectiveness of the CHARLOTTETM Compression Plate is adequately supported by the substantial equ…	Wrightmedicaltechnologyinc	2005	—

Also cleared against K043059: 9 other devices →

What descends from it? (149)

See all 149

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

Number	Device	Applicant	Decided	Descendants
K070447	Newdeal Compression Plate	Newdeal Sas	2007	102
K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	97
K092528	Biomet Forerunner Locking Plate System	Biomet Trauma (Aka Ebi, Lp)	2010	53
K122334	Checkmate Small Bone Fusion System	Arthrosurface, Inc.	2012	5
K161303	dynaMX™ Compression Plate	Mx Orthopedics, Corp.	2017	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, K070447 (Newdeal Sas, 2007) has gone furthest, with 102 descendants of its own.
9 other devices also cite its predicate K043059.

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 Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051908 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051908: Charlotte Compression Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051908

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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