510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

FuseForce™ Flex Dynamic Compression System

K203832510(k) TraditionalCleared May 7, 2021128-day reviewClass II21 CFR 888.3030Recalls 1

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

Wright Medical · JDR Staple, Fixation, Bone

Cleared on May 7, 2021 as substantially equivalent to K124045 (Solana Surgical, LLC, 2013) after a 128-day review. Its family tree reaches back 4 generations to 1990. 8 later devices descend from it. It has been recalled once.

Decided
May 7, 2021
Review
128 days
Class
Class II
Product code
JDR
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K902307 (1990). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2022: 1 descendant cleared2025: 2 descendants cleared2024: 3 descendants cleared2023: 1 descendant cleared2026: 1 descendant clearedReference device: K161587 · Memodyn Staple · Austin & Associates, Inc./Telos Medical Equipment · 2017K902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalledK993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K070031 · Memometal Memory Staples · Memometal Technologies · 2007K124045 · Fuseforce Implant System · Solana Surgical, LLC · 20131990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K124045 · Fuseforce Implant System · Solana Surgical, LLC · 2013K070031 · Memometal Memory Staples · Memometal Technologies · 2007K993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalled0+5
  1. Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
  4. 1 generation backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
  5. This deviceK203832 FuseForce™ Flex Dynamic Compression SystemWright Medical · 2021
  6. Descendant · cites it directly · 6 of its ownK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
  7. Descendant · 2 generations on · 4 of its ownK232387 Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023
  8. Descendant · 3 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
  9. Descendant · 4 generations on · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
  10. Descendant · 5 generations on · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2022: 12023: 12024: 32025: 22026: 1
2022high 3 (2024) · low 1 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022 · cites it directly6descendants
  • K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023 · 2 generations on4descendants
  • K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 3 generations on3descendants
  • K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · 4 generations on2descendants
  • K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−3K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−2K070031Memometal Memory StaplesMemometal Technologies2007—
−1K124045Fuseforce Implant SystemSolana Surgical, LLC2013—
0 (this device)K203832FuseForce™ Flex Dynamic Compression SystemWright Medical2021—
+1K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts2022—
+2K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts2023—
+3K242415TMC Compression Implant SystemTreace Medical Concepts2024—
+4K243658TMC Compression Implant SystemTreace Medical Concepts2024—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
202430
202520
202610
FIG. 1 — Lineage of K203832, 1990–2026Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K124045Fuseforce Implant System
Summary page 4
…s II Device Product Code & Panel: JDR – Orthopedic (a)(3) PREDICATE DEVICE INFORMATION FuseForce™ Implant System K124045 Memodyn Staple K161587 (reference) (a)(4) DEVICE DESCRIPTON The FuseForce™…
Solana Surgical, LLC2013—
†K161587Memodyn StapleAustin & Associates, Inc./Telos Medical Equipment2017—

Also cleared against K124045: 5 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226
K250712Linkt Compression Staple SystemTrax Surgical20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 10, 2022Class IIZ-0853-2022Device DesignThe drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K222645 (Treace Medical Concepts, 2022) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K124045.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

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 FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

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

Also cleared against K124045

5 other devices cite the same predicate.

  • K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc. · 2021
  • K181781DynaClipTM Bone StapleMedShape, Inc. · 2018
  • K163440Stealth Staple SystemFirst Ray, LLC · 2017
  • K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 20141 recall
  • K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014

More from Wright Medical

3 FDA decisions under this applicant name. See the company

  • K203228DART-FIRE EDGE Cannulated Screw SystemWright Medical · 2021
  • K162033SALVATION External Fixation SystemWright Medical · 2017

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/K203832 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203832: FuseForce™ Flex Dynamic Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203832

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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