510(k) · Cleared

Cleared

Sijf Cannulated Screw System

K051296510(k) TraditionalCleared Aug 26, 2005100-day reviewClass II21 CFR 888.3040

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

Depuy Spine, Inc. · OUR Sacroiliac Joint Fixation

Cleared on Aug 26, 2005 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 2 other predicates after a 100-day review. Its family tree reaches back 1 generation to 1990. 1 of the 840 devices in its family, counting itself, has a Class I recall. 836 later devices descend from it.

Decided: Aug 26, 2005
Review: 100 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K903810 (1990). 3 ancestors in all. 836 later devices descend from it, 6 citing it directly. 1 of the 840 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
This deviceK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
Descendant · cites it directly · 531 of its ownK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
Descendant · cites it directly · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
Descendant · 2 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Descendant · 3 generations on · 240 of its ownK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011

Showing 5 of 836 descendants. See all descendants

Descendants cleared per year

2006high 96 (2024) · low 1 (2006)2026

Class I recalls in this family

K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 836 · See all

K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · cites it directly531descendants
K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · cites it directly245descendants
K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 2 generations on241descendants
K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on240descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw	Ace Medical Co.	1990	—
0 (this device)	K051296	Sijf Cannulated Screw System	Depuy Spine, Inc.	2005	—
+1	K060736	Smith & Nephew 6.5MM and 8.0MM Cannulated Screws	Smith & Nephew, Inc.	2006	1
+2	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
+1	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
+2	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
+3	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	3	0
2009	5	0
2010	6	0
2011	9	0
2012	15	0
2013	14	0
2014	29	0
2015	36	0
2016	25	0
2017	50	0
2018	33	0
2019	38	0
2020	54	0
2021	69	1
2022	75	0
2023	93	0
2024	96	0
2025	90	0
2026	94	0

FIG. 1 — Lineage of K051296, 1990–2026Source: 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.

1 device in this family has a Class I recall. 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 OUR device

#1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K000080	Asnis Iii Cannulated Screw System Summary page 1 …CRIPTION: INTENDED USE: MATERIALS: PERFORMANCE DATA: DePuy Spine, Inc. Traditional 510(k) K051296 SIJF Cannulated Screw System Stryker Asnis llf Cannulated Screws (K000080 and K024060) ACE Medical Cannulated Screws (K903810) SIJF Cannulated Screws consists of cannulated screws available in titanium…	Howmedica Osteonics Corp.	2000	1
*	K024060	Modification to Asnis Iii Cannulated Screw System Summary page 1 …NTENDED USE: MATERIALS: PERFORMANCE DATA: DePuy Spine, Inc. Traditional 510(k) K051296 SIJF Cannulated Screw System Stryker Asnis llf Cannulated Screws (K000080 and K024060) ACE Medical Cannulated Screws (K903810) SIJF Cannulated Screws consists of cannulated screws available in titanium in two diame…	Howmedica Osteonics Corp.	2002	—
*	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw Summary page 1 …TA: DePuy Spine, Inc. Traditional 510(k) K051296 SIJF Cannulated Screw System Stryker Asnis llf Cannulated Screws (K000080 and K024060) ACE Medical Cannulated Screws (K903810) SIJF Cannulated Screws consists of cannulated screws available in titanium in two diameters of 6.5mm and 8.0mm with lengths ran…	Ace Medical Co.	1990	—

Also cleared against K000080: 20 other devices →

What descends from it? (836)

See all 836

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

Number	Device	Applicant	Decided	Descendants
K060736	Smith & Nephew 6.5MM and 8.0MM Cannulated Screws	Smith & Nephew, Inc.	2006	531
K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	245
K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	238
K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	168
K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	144
K110472	SI-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	2012	92

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K060736 (Smith & Nephew, Inc., 2006) has gone furthest, with 531 descendants of its own.
20 other devices also cite its predicate K000080.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OUR

14in 2025

2007high 20 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUR

97in 2025

2007high 168 (2016) · low 27 (2011)2026

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

Recalls per year · OUR

1in 2025

2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · OUR

10in 2025

2007high 175 (2019) · low 0 (2007)2025

MAUDE reports naming product code OUR, 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	0	—	0	0
2008	1	—	0	0
2009	1	—	0	0
2010	1	—	0	0
2011	3	27	0	6
2012	2	—	0	81
2013	4	103	0	96
2014	3	91	0	146
2015	8	111	0	119
2016	6	168	0	122
2017	4	120	0	157
2018	7	82	0	137
2019	7	89	0	175
2020	7	88	0	148
2021	9	85	0	154
2022	14	149	0	23
2023	20	55	0	7
2024	15	74	0	15
2025	14	97	1	10
2026	6	98	1	—

What is it indicated for?

The SIJF Cannulated Screw is intended for fracture fixation of long bones and of the pelvis for such conditions as degenerative sacroiliitis, trauma (fracture and/or dislocation) or tumor, iatrogenic instability and Osteitis Condensans llii. The system is not intended for spinal use.

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/K051296 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051296: Sijf Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051296

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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