510(k) Report

510(k) · Cleared

Cleared

Lactosorb Pop Rivet

K951658510(k) TraditionalCleared Jul 25, 1995106-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

Poly-Medics,Inc. · JDR Staple, Fixation, Bone

Cleared on Jul 25, 1995 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided
Jul 25, 1995
Review
106 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

29 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2007: 1 descendant cleared1997: 1 descendant cleared2009: 2 descendants cleared2013: 4 descendants cleared2011: 1 descendant cleared2023: 3 descendants cleared2015: 2 descendants cleared2012: 2 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 3 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2019: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
  2. Descendant · cites it directly · 28 of its ownK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
  3. Descendant · 2 generations on · 26 of its ownK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  4. Descendant · 3 generations on · 12 of its ownK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
  5. Descendant · 3 generations on · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
  6. Descendant · 4 generations on · 11 of its ownK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1996: 11997: 12007: 12009: 22010: 12011: 12012: 22013: 42014: 22015: 22016: 32017: 12019: 22021: 12022: 12023: 32026: 1
1996high 4 (2013) · low 0 (1998)2026

Most influential descendants

Showing 5 of 29 · See all
  • K961585Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996 · cites it directly28descendants
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007 · 2 generations on26descendants
  • K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009 · 3 generations on12descendants
  • K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · 3 generations on12descendants
  • K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc. · 2010 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951658Lactosorb Pop RivetPoly-Medics,Inc.1995—
+1K961585Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc1996—
+2K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc2007—
+3K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States2009—
+3K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien20092
+4K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
200710
200920
201010
201110
201220
201340
201420
201520
201630
201710
201920
202110
202210
202330
202610
FIG. 1 — Lineage of K951658, 1995–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K961585Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc199628

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, K961585 (United States Surgical, A Division of Tyco Healthc, 1996) has gone furthest, with 28 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—

More from Poly-Medics,Inc.

5 FDA decisions under this applicant name. See the company

  • K960988Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 1996
  • K955729Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 19961 recall
  • K954443Lactosorb Suture AnchorPoly-Medics,Inc. · 1996
  • K934861Hard Tissue Replacement (HTR) GranularPoly-Medics,Inc. · 1994

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https://510kreport.com/device/K951658 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951658: Lactosorb Pop Rivet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951658

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026