510(k) Report

510(k) · Cleared

Cleared

Memory Staple

K060746510(k) TraditionalCleared May 25, 200666-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

DePuy Orthopaedics, Inc. · JDR Staple, Fixation, Bone

Cleared on May 25, 2006 as substantially equivalent to K964226 (Landos, Inc., 1997) after a 66-day review. Its family tree reaches back 1 generation to 1997. 59 later devices descend from it.

Decided
May 25, 2006
Review
66 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K964226 (1997). 59 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2024: 8 descendants cleared2015: 6 descendants cleared2017: 6 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2022: 3 descendants cleared2026: 7 descendants cleared2020: 4 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2025: 5 descendants cleared2023: 9 descendants cleared2021: 4 descendants clearedK964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 8 descendants3 generations forward: 16 descendants4 generations forward: 14 descendants5 generations forward: 11 descendants6 generations forward: 5 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 19970+5
  1. Root · 1 generation backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  2. This deviceK060746 Memory StapleDePuy Orthopaedics, Inc. · 2006
  3. Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  4. Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  5. Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  6. Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
  7. Descendant · 3 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22015: 62016: 12017: 62019: 22020: 42021: 42022: 32023: 92024: 82025: 52026: 7
2012high 9 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 59 · See all
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
  • K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964226Memory Staple (20 Sizes Available)Landos, Inc.1997—
0 (this device)K060746Memory StapleDePuy Orthopaedics, Inc.2006—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited20142
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132
+2K162674BioPro Foot Plating SystemsBiopro, Inc.2017—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201420
201560
201610
201760
201920
202040
202140
202230
202390
202480
202550
202670
FIG. 1 — Lineage of K060746, 1997–2026Source: 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
*K964226Memory Staple (20 Sizes Available)
Summary page 1
…threaded metallic bone fixation fastener DEVICE PRODUCT CODE: 87 JDR SUBSTANTIALLY EQUIVALENT DePuy Memory Staple (Size 12), K964226, DEVICES: cleared on August 5, 1997 DEVICE DESCRIPTION: The Memory Staple is a single-use, bo…
Landos, Inc.1997—

Also cleared against K964226: 6 other devices →

What descends from it? (59)

See all 59

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

NumberDeviceApplicantDecidedDescendants
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258

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, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 descendants of its own.
  • 6 other devices also cite its predicate K964226.

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?

Memory 12 and Memory 20 staples are implants intended for fixation of the foot.

Memory 12 staples are indicated for osteotomies of the first phalanx of the foot.

Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.

The patient's anatomy and skeleton must be capable of receiving the selected implant.

Indications for use as stated in the FDA summary.

Also cleared against K964226

6 other devices cite the same predicate.

  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall
  • K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  • K070031Memometal Memory StaplesMemometal Technologies · 2007
  • K011716The Uni-Clip StapleNew Deal, S.A. · 20011 recall
  • K993714Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  • K991482Uni-Clip StapleNew Deal, S.A. · 1999

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K060746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060746: Memory Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060746

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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