510(k) Report

510(k) · Cleared

Cleared

Mli Modular Staple

K962705510(k) TraditionalCleared Oct 1, 199681-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

Medicinelodge, Inc. · JDR Staple, Fixation, Bone

Cleared on Oct 1, 1996 as substantially equivalent to K894929 (Concept, Inc., 1989) after an 81-day review. Its family tree reaches back 1 generation to 1989. 25 later devices descend from it.

Decided
Oct 1, 1996
Review
81 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K894929 (1989). 25 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2018: 2 descendants cleared2013: 2 descendants cleared2022: 1 descendant cleared2023: 3 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2024: 5 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant clearedK894929 · Staple Fixation System · Concept, Inc. · 19891990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant K894929 · Staple Fixation System · Concept, Inc. · 19890+5
  1. Root · 1 generation backK894929 Staple Fixation SystemConcept, Inc. · 1989
  2. This deviceK962705 Mli Modular StapleMedicinelodge, Inc. · 1996
  3. Descendant · cites it directly · 24 of its ownK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
  4. Descendant · 2 generations on · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
  5. Descendant · 3 generations on · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
  6. Descendant · 2 generations on · 6 of its ownK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
  7. Descendant · 4 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22015: 22017: 22018: 22019: 12020: 12021: 22022: 12023: 32024: 52025: 12026: 2
2012high 5 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 25 · See all
  • K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG · 2012 · cites it directly24descendants
  • K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · 2 generations on15descendants
  • K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · 3 generations on8descendants
  • K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022 · 2 generations on6descendants
  • K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894929Staple Fixation SystemConcept, Inc.1989—
0 (this device)K962705Mli Modular StapleMedicinelodge, Inc.1996—
+1K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG2012—
+2K131061Restore Bunion Correction SystemNextremity Solutions2013—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC2017—
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts2022—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201520
201720
201820
201910
202010
202120
202210
202330
202450
202510
202620
FIG. 1 — Lineage of K962705, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K894929Staple Fixation System
Summary page 5
…terile & Non-sterile Sterile & Non-sterile Manufacturer MedicineLodge, Inc. Smith & Nephew Richards, Inc. Linvatec, inc. 510(k) Approved? N/A Presumed Preamendment Yes - K894929 33
Concept, Inc.1989—
*—Richards Fixation Staples
Named without a submission number
—

What descends from it? (25)

See all 25

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224

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, K121277 (Z-Medical GmbH & Co. KG, 2012) has gone furthest, with 24 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?

MedicineLodge, Inc. (MLI) Modular Staples are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

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

More from Medicinelodge, Inc.

8 FDA decisions under this applicant name. See the company

  • K072525Zipknot, Model 1017-3000Medicinelodge, Inc. · 2007
  • K051488Medicinelodge ZipknotMedicinelodge, Inc. · 2005
  • K961920Cross PinMedicinelodge, Inc. · 1996
  • K961905Medicinelodge, Inc. Set ScrewMedicinelodge, Inc. · 1996
  • K962194Mli Soft Tissue Screw & Washer SystemMedicinelodge, Inc. · 1996

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/K962705 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962705: Mli Modular Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962705

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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