510(k) Report

510(k) · Cleared

Cleared

Fuseforce Implant System

K124045510(k) TraditionalCleared Jul 10, 2013191-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

Solana Surgical, LLC · JDR Staple, Fixation, Bone

Cleared on Jul 10, 2013 as substantially equivalent to K070031 (Memometal Technologies, 2007) after a 191-day review. Its family tree reaches back 3 generations to 1990. 29 later devices descend from it.

Decided
Jul 10, 2013
Review
191 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K902307 (1990). 4 ancestors in all. 29 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2018: 4 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2021: 2 descendants cleared2019: 1 descendant cleared2022: 2 descendants cleared2026: 4 descendants cleared2025: 3 descendants cleared2023: 6 descendants cleared2020: 1 descendant cleared2024: 3 descendants clearedK902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalledK993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K070031 · Memometal Memory Staples · Memometal Technologies · 20071990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 10 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K070031 · 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 · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 1 generation backK070031 Memometal Memory StaplesMemometal Technologies · 2007
  4. This deviceK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
  5. Descendant · cites it directly · 8 of its ownK203832 FuseForce™ Flex Dynamic Compression SystemWright Medical · 2021 · Recalled
  6. Descendant · cites it directly · 8 of its ownK142727 CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014 · Recalled
  7. Descendant · 2 generations on · 6 of its ownK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
  8. Descendant · 2 generations on · 6 of its ownK181410 MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC · 2018
  9. Descendant · 3 generations on · 4 of its ownK232387 Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2014: 22017: 12018: 42019: 12020: 12021: 22022: 22023: 62024: 32025: 32026: 4
2014high 6 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 29 · See all
  • K203832FuseForce™ Flex Dynamic Compression SystemWright Medical · 2021 · cites it directly8descendants
  • K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014 · cites it directly8descendants
  • K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022 · 2 generations on6descendants
  • K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC · 2018 · 2 generations on6descendants
  • K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−2K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−1K070031Memometal Memory StaplesMemometal Technologies2007—
0 (this device)K124045Fuseforce Implant SystemSolana Surgical, LLC2013—
+1K203832FuseForce™ Flex Dynamic Compression SystemWright Medical20211
+1K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems20141
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts2022—
+2K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC2018—
+3K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201710
201840
201910
202010
202120
202220
202360
202430
202530
202640
FIG. 1 — Lineage of K124045, 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
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.

TypeNumberDeviceApplicantDecidedRecalls
*K070031Memometal Memory Staples
Summary page 1
…Orthopedic Regulation Number: 21 CFR 888.3030 Product Code: JOR Predicate Device: K070031 Memometal Memory Staples Device Description: The Solana Surgical FuseForce Implant is a one-piece device made of Nickel Titanium…
Memometal Technologies2007—

Also cleared against K070031: 12 other devices →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K203832FuseForce™ Flex Dynamic Compression SystemWright Medical20218
K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems20148
K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.20214
K163440Stealth Staple SystemFirst Ray, LLC20173
K181781DynaClipTM Bone StapleMedShape, Inc.20182
K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140

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 23 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K203832 (Wright Medical, 2021) has gone furthest, with 8 descendants of its own.
  • 12 other devices also cite its predicate K070031.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Solana Surgical, LLC FuseForce Implant System is intended to provide fixation for

fractures, fusions or osteotomies of the bones of the hand and foot such as: LisFrane

arthradesis, Akin Osteotomy, Scarf and Chevron osteotomies

Indications for use as stated in the FDA summary.

Also cleared against K070031

12 other devices cite the same predicate.

  • K192447Superelastic StapleNeosteo · 2020
  • K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016
  • K153395OS2-C Compression StapleIn2bones Sas · 2016
  • K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 20141 recall
  • K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
  • K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014

More from Solana Surgical, LLC

8 FDA decisions under this applicant name. See the company

  • K132594Crosscheck Plating SystemSolana Surgical, LLC · 201321 recalls
  • K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC · 2013
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
  • K120390Solafix Twist Screw Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
  • K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC · 2012

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/K124045 · printed Nov 5, 2026

Cite this page

510(k) Report. “K124045: Fuseforce Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K124045

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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