510(k) · Cleared

Cleared

Synthes Cerclage Positioning Pin

K992891510(k) TraditionalCleared Nov 2, 199967-day reviewClass II21 CFR 888.3010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Nov 2, 1999 as substantially equivalent to K953777 (Synthes (Usa), 1996) after a 67-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.

Decided: Nov 2, 1999
Review: 67 days
Class: Class II
Product code: JDQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953777 (1996). 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK953777 Synthes Wire MountSynthes (Usa) · 1996
This deviceK992891 Synthes Cerclage Positioning PinSynthes (Usa) · 1999
Descendant · cites it directly · 7 of its ownK091799 Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009
Descendant · 2 generations on · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
Descendant · cites it directly · 2 of its ownK172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
Descendant · 3 generations on · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009high 2 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all

K091799Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009 · cites it directly7descendants
K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · 2 generations on6descendants
K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly2descendants
K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953777	Synthes Wire Mount	Synthes (Usa)	1996	—
0 (this device)	K992891	Synthes Cerclage Positioning Pin	Synthes (Usa)	1999	—
+1	K091799	Cable Ready Cable Grip System Cable Button	Zimmer, Inc.	2009	—
+2	K120772	NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB…	Zimmer GmbH	2012	2
+1	K172975	DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	—
+2	K243995	Arthrex Humeral Plating System and Cerclage Button	Arthrex, Inc.	2025	—
+3	K210247	OsteoCentric Integrated Hip Fastener System	Osteocentric Technologies D.B.A. Osteocentric Trauma	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2017	2	0
2018	1	0
2021	2	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K992891, 1996–2026Source: 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 JDQ? 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 JDQ device

#1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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
*	K953777	Synthes Wire Mount Summary page 1 …ing Pin COMMON OR USUAL Smooth or thread metallic bone fixation fastener NAME DEVICE Class I1, 21 CFR 888.3040 CLASSIFICATION: PREDICATE DEVICE: Synthes Wire Mount (K953777) DESCRIPTION: The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (fo…	Synthes (Usa)	1996	—

Also cleared against K953777: 2 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K091799	Cable Ready Cable Grip System Cable Button	Zimmer, Inc.	2009	7
K172975	DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	2
K172786	MDS Plating System	Miami Device Solutions, LLC	2017	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, K091799 (Zimmer, Inc., 2009) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K953777.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDQ

84in 2025

2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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	1	—	0	5
2008	2	—	2	25
2009	2	—	0	19
2010	0	—	2	28
2011	6	130	0	30
2012	3	134	0	130
2013	1	—	1	321
2014	2	—	0	223
2015	5	92	1	205
2016	4	129	0	224
2017	1	—	0	138
2018	6	101	0	182
2019	0	—	5	158
2020	4	93	0	125
2021	0	—	0	141
2022	2	—	0	134
2023	3	141	0	98
2024	3	130	0	115
2025	2	—	0	84
2026	1	—	0	—

What is it indicated for?

Synthes Cerclage Positioning Pin is intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.

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/K992891 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992891: Synthes Cerclage Positioning Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992891

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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