510(k) Report

510(k) · Cleared

Cleared

Biopro Memory Staple

K061798510(k) TraditionalCleared Aug 21, 200656-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

Biopro, Inc. · JDR Staple, Fixation, Bone

Cleared on Aug 21, 2006 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 65 later devices descend from it.

Decided
Aug 21, 2006
Review
56 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

65 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2017: 7 descendants cleared2022: 4 descendants cleared2020: 5 descendants cleared2012: 1 descendant cleared2024: 8 descendants cleared2015: 6 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2023: 11 descendants cleared2026: 8 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2025: 5 descendants cleared2021: 4 descendants cleared20052010201520202025
  1. This deviceK061798 Biopro Memory StapleBiopro, Inc. · 2006
  2. Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  3. Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  4. Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  5. Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
  6. Descendant · 3 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22015: 62016: 12017: 72019: 22020: 52021: 42022: 42023: 112024: 82025: 52026: 8
2012high 11 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 65 · 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
0 (this device)K061798Biopro Memory StapleBiopro, 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
201770
201920
202050
202140
202240
2023110
202480
202550
202680
FIG. 1 — Lineage of K061798, 2006–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K170923JAWS (TM) Nitinol Staple SystemParagon 2820173
K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220
K192447Superelastic StapleNeosteo20200

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?

  • Of its descendants, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 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?

1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.

2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

Indications for use as stated in the FDA 510(k) statement.

More from Biopro, Inc.

41 FDA decisions under this applicant name. See the company

  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 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/K061798 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061798: Biopro 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/K061798

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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