510(k) Report

510(k) · Cleared

Cleared

Linkt Compression Staple System

K250712510(k) TraditionalCleared May 14, 202565-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

Trax Surgical · JDR Staple, Fixation, Bone

Cleared on May 14, 2025 as substantially equivalent to K203832 (Wright Medical, 2021) and 2 other predicates after a 65-day review. Its family tree reaches back 6 generations to 1990.

Decided
May 14, 2025
Review
65 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K902307 (1990). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2021: 1 other ancestor1997: 1 other ancestorK902307 · 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 · 2013K210482 · Medline UNITE REFLEX Nitinol Staple System · Medline Industries, Inc. · 2021K231885 · Medline UNITE® REFLEX® Nitinol Staple System · Medline Industries, LP · 20231990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor4 generations back: 1 other ancestor K231885 · Medline UNITE® REFLEX® Nitinol Staple System · Medline Industries, LP · 2023K210482 · Medline UNITE REFLEX Nitinol Staple System · Medline Industries, Inc. · 2021K124045 · 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 · recalled−50
  1. Root · 6 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 5 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 4 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
  4. 3 generations backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
  5. 2 generations backK210482 Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc. · 2021
  6. 1 generation backK231885 Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP · 2023
  7. This deviceK250712 Linkt Compression Staple SystemTrax Surgical · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−5K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−4K070031Memometal Memory StaplesMemometal Technologies2007—
−3K124045Fuseforce Implant SystemSolana Surgical, LLC2013—
−2K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.2021—
−1K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP2023—
0 (this device)K250712Linkt Compression Staple SystemTrax Surgical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
202110
FIG. 1 — Lineage of K250712, 1990–2025Source: 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? (3)

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
*K203832FuseForce™ Flex Dynamic Compression System
Summary page 5
…Device Class: 2 Review Panel: Orthopedic Primary Predicate Device: Wright Medical FuseForce Flex Dynamic Compression System (K203832) Additional Predicate Devices: Medline Unite Reflex Nitinol Staple System (K210482)…
Wright Medical20211
*K210482Medline UNITE REFLEX Nitinol Staple System
Summary page 5
…cate Device: Wright Medical FuseForce Flex Dynamic Compression System (K203832) Additional Predicate Devices: Medline Unite Reflex Nitinol Staple System (K210482) Medline Unite Reflex Nitinol Staple System (K231885) Device Description The Linkt Compr…
Medline Industries, Inc.2021—
*K231885Medline UNITE® REFLEX® Nitinol Staple System
Summary page 5
…ional Predicate Devices: Medline Unite Reflex Nitinol Staple System (K210482) Medline Unite Reflex Nitinol Staple System (K231885) Device Description The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a…
Medline Industries, LP2023—

Also cleared against K203832: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 35 years and passes through 7 companies; a new generation was cleared every 7.1 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 1 other device also cites its predicate K203832.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Linkt ™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Indications for use as stated in the FDA summary.

Also cleared against K203832

1 other device cites the same predicate.

  • K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022

More from Trax Surgical

2 FDA decisions under this applicant name. See the company

  • K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium…Trax Surgical · 2023

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
  • K243658TMC Compression Implant SystemTreace Medical Concepts · 2024

https://510kreport.com/device/K250712 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250712: Linkt Compression Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250712

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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