510(k) · Cleared

Cleared

Surgical Dynamics Pop Rivet

K961585510(k) TraditionalCleared Jul 10, 199677-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

United States Surgical, A Division of Tyco Healthc · JDR Staple, Fixation, Bone

Cleared on Jul 10, 1996 as substantially equivalent to K951658 (Poly-Medics,Inc., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995. 28 later devices descend from it.

Decided: Jul 10, 1996
Review: 77 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951658 (1995). 28 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
This deviceK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
Descendant · cites it directly · 26 of its ownK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
Descendant · 2 generations on · 12 of its ownK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
Descendant · 2 generations on · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
Descendant · 3 generations on · 11 of its ownK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled
Descendant · 3 generations on · 4 of its ownK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1997high 4 (2013) · low 0 (1998)2026

Most influential descendants

Showing 5 of 28 · See all

K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007 · cites it directly26descendants
K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009 · 2 generations on12descendants
K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · 2 generations on12descendants
K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc. · 2010 · 3 generations on11descendants
K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951658	Lactosorb Pop Rivet	Poly-Medics,Inc.	1995	—
0 (this device)	K961585	Surgical Dynamics Pop Rivet	United States Surgical, A Division of Tyco Healthc	1996	—
+1	K071920	Autosuture Absorbable Tack and Applicator	United States Surgical, A Division of Tyco Healthc	2007	—
+2	K091900	Absorbatack 5MM Single Use Absorbable Fixation Device	Covidien Lp, Formerly Registered AS United States	2009	—
+2	K090470	Autosuture Protack; Tacker System; Absorbatack Fixation Devices	Covidien	2009	2
+3	K093845	Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25	ETHICON, Inc.	2010	1
+3	K123109	Absorbatack 5MM Single Use Absorbable Fixation Device	Covidien	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2007	1	0
2009	2	0
2010	1	0
2011	1	0
2012	2	0
2013	4	0
2014	2	0
2015	2	0
2016	3	0
2017	1	0
2019	2	0
2021	1	0
2022	1	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K961585, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951658	Lactosorb Pop Rivet Summary page 1 …ng, sterilization, packaging and method of use, the Surgical Dynamics™ Pop Rivet™ is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Pop Rivet (K951658) and other currently market devices by United States Surgical Corporation. Both the Surgical Dynamics™ Pop Rivet*™ and the Poly-…	Poly-Medics,Inc.	1995	—

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K071920	Autosuture Absorbable Tack and Applicator	United States Surgical, A Division of Tyco Healthc	2007	26
K973281	The Surgical Dynamics* S.D. Sorb* E-Z Tac*	United States Surgical, A Division of Tyco Healthc	1997	0

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, K071920 (United States Surgical, A Division of Tyco Healthc, 2007) has gone furthest, with 26 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

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDR

11in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

Both the Surgical Dynamics™ Pop Rivet*™ and the Poly-Medics Lactosorb® Pop Rivet (K951658) are indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

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

https://510kreport.com/device/K961585 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961585: Surgical Dynamics Pop Rivet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961585

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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