510(k) Report

510(k) · Cleared

Cleared

Compression Staple and Simple Staple

K043059510(k) TraditionalCleared Jan 18, 200574-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 · JDR Staple, Fixation, Bone

Cleared on Jan 18, 2005 after a 74-day review. The FDA summary names no predicate by number. 207 later devices descend from it.

Decided
Jan 18, 2005
Review
74 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

207 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2013: 7 descendants cleared2007: 2 descendants cleared2017: 21 descendants cleared2012: 8 descendants cleared2005: 1 descendant cleared2011: 2 descendants cleared2018: 10 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2015: 15 descendants cleared2024: 18 descendants cleared2014: 11 descendants cleared2022: 14 descendants cleared2023: 19 descendants cleared2025: 14 descendants cleared2009: 1 descendant cleared2020: 19 descendants cleared2016: 8 descendants cleared2026: 15 descendants cleared2019: 8 descendants cleared2021: 12 descendants cleared20052010201520202025
  1. This deviceK043059 Compression Staple and Simple StapleWrightmedicaltechnologyinc · 2005
  2. Descendant · cites it directly · 149 of its ownK051908 Charlotte Compression PlateWrightmedicaltechnologyinc · 2005
  3. Descendant · 2 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
  4. Descendant · 3 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
  5. Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  6. Descendant · 3 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 207 descendants. See all descendants

Descendants cleared per year

2005: 12007: 22008: 12009: 12010: 12011: 22012: 82013: 72014: 112015: 152016: 82017: 212018: 102019: 82020: 192021: 122022: 142023: 192024: 182025: 142026: 15
2005high 21 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 207 · See all
  • K051908Charlotte Compression PlateWrightmedicaltechnologyinc · 2005 · cites it directly149descendants
  • K070447Newdeal Compression PlateNewdeal Sas · 2007 · 2 generations on102descendants
  • K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 3 generations on98descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 3 generations on95descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043059Compression Staple and Simple StapleWrightmedicaltechnologyinc2005—
+1K051908Charlotte Compression PlateWrightmedicaltechnologyinc2005—
+2K070447Newdeal Compression PlateNewdeal Sas20072
+3K093914Newdeal Compression PlatesNewdeal Sas20115
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+3K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200720
200810
200910
201010
201120
201280
201370
2014110
2015150
201680
2017210
2018100
201980
2020190
2021120
2022140
2023190
2024180
2025140
2026150
FIG. 1 — Lineage of K043059, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (207)

See all 207

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

NumberDeviceApplicantDecidedDescendants
K051908Charlotte Compression PlateWrightmedicaltechnologyinc2005149
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224
K080111Arthrex Compression StapleArthrex, Inc.20089
K122871Compressyn StapleDallen Medical, Inc.20134
K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.20171
K163226EPIC Extremely Small StapleEpic Extremely, LLC20171
K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180
K102387Mediscope Compressiopn Staple and AccessoriesMediscope Manufacturing, Inc.20110
K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070

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?

  • Of its descendants, K051908 (Wrightmedicaltechnologyinc, 2005) has gone furthest, with 149 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, 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.

The Simple Staple is intended to be used for wedge osteotomy of the first phalanx (Akin osteotomy), in the treatment of hallux-valgus in order to correct a remaining valgus or pronation of the first ray, and external rotation, and wind-swept toes.

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K043059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043059: Compression Staple and Simple Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043059

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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