510(k) · Cleared

Cleared

Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)

K063009510(k) TraditionalCleared Dec 27, 200686-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

Praesidia S.R.L. · HRS Plate, Fixation, Bone

Cleared on Dec 27, 2006 as substantially equivalent to K974016 (Pioneer Surgical Technology, 1997) and 3 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.

Decided: Dec 27, 2006
Review: 86 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K875156 (1988). 14 ancestors in all, the oldest K844068 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK875156 Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc. · 1988
3 generations backK961283 Dall-Miles Homogenous Vitallium CableHowmedica Corp. · 1996
2 generations backK972327 Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
1 generation backK983976 Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
This deviceK063009 Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None…Praesidia S.R.L. · 2006
Descendant · cites it directly · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009

Most influential descendants

Showing 1 of 1 · See all

K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K875156	Stainless Steel Orthopaedic Cable System	Richards Medical Co., Inc.	1988	—
−3	K961283	Dall-Miles Homogenous Vitallium Cable	Howmedica Corp.	1996	—
−2	K972327	Metagen Activelock Cerclage System	Pacific Materials and Interfaces	1997	—
−1	K983976	Metagen Activelock Wire Cerclage System	Metagen, LLC	1998	—
0 (this device)	K063009	Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)	Praesidia S.R.L.	2006	—
+1	K090686	Sic Brevetti S.R.L. Device for Sternal Synthesis	Sic Brevetti S.R.L.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1990	1	0
1994	2	0
1995	2	0
1996	1	0
1997	1	0
2003	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K063009, 1988–2009Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (5)

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
*	K974016	Cerclage Cable with Hex Button Summary page 1 …21 CFRSSS.301 0 R7JDQ Class: II Substantial Equivalence: Pioneer Surgical Technology, Cerciage cable with hex button, 1K974016 Synthes (USA), Synthes sterile sternal fixation system, K050041 Kinamned Inc., Iso-Elastic Cerciage System, K030256…	Pioneer Surgical Technology	1997	—
*	K050041	Synthes (Usa) Sterile Sternal Fixation System Summary page 1 …II Substantial Equivalence: Pioneer Surgical Technology, Cerciage cable with hex button, 1K974016 Synthes (USA), Synthes sterile sternal fixation system, K050041 Kinamned Inc., Iso-Elastic Cerciage System, K030256 Mecagen, Activelock Wire Cerciage System, K983976 Standa…	Synthes (Usa)	2005	—
*	K030256	Iso-Elastic Cerclage System Summary page 1 …ology, Cerciage cable with hex button, 1K974016 Synthes (USA), Synthes sterile sternal fixation system, K050041 Kinamned Inc., Iso-Elastic Cerciage System, K030256 Mecagen, Activelock Wire Cerciage System, K983976 Standard sternal wires, 5 10(k) not applicable due to preamendmen…	Kinamed, Inc.	2003	—
*	K983976	Metagen Activelock Wire Cerclage System Summary page 1 …nthes (USA), Synthes sterile sternal fixation system, K050041 Kinamned Inc., Iso-Elastic Cerciage System, K030256 Mecagen, Activelock Wire Cerciage System, K983976 Standard sternal wires, 5 10(k) not applicable due to preamendment status Device Description The device consists of a sp…	Metagen, LLC	1998	—
*	—	Standard sternal wires Named without a submission number			—

Also cleared against K974016: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K090686	Sic Brevetti S.R.L. Device for Sternal Synthesis	Sic Brevetti S.R.L.	2009	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?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K090686 (Sic Brevetti S.R.L., 2009) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K974016.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Flexigrip Sternal Closure System is intended for use in closure or repair of the sternum after strenotomy, fracture or dehiscence.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063009 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063009: Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063009

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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