510(k) · Cleared

Cleared

Alphatec Cannulated Bone Screws

K914004510(k) TraditionalCleared Dec 5, 199190-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

Alphatec Mfg., Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 5, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 93 later devices descend from it.

Decided: Dec 5, 1991
Review: 90 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK914004 Alphatec Cannulated Bone ScrewsAlphatec Mfg., Inc. · 1991
Descendant · cites it directly · 92 of its ownK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
Descendant · 2 generations on · 79 of its ownK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
Descendant · 2 generations on · 30 of its ownK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
Descendant · 3 generations on · 22 of its ownK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
Descendant · 4 generations on · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2012high 22 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 93 · See all

K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012 · cites it directly92descendants
K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek · 2016 · 2 generations on79descendants
K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018 · 2 generations on30descendants
K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019 · 3 generations on22descendants
K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · 4 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914004	Alphatec Cannulated Bone Screws	Alphatec Mfg., Inc.	1991	—
+1	K110472	SI-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	2012	—
+2	K161210	RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the…	Medtronic Sofamor Danek	2016	—
+2	K180818	Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)	Tenon Medical, Inc.	2018	—
+3	K191748	Genesys Spine Sacroiliac Joint Fusion System	Genesys Spine	2019	—
+4	K203247	iFuse-TORQ™ Implant System	SI-BONE, Inc.	2021	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2016	3	0
2018	2	0
2019	3	0
2020	1	0
2021	8	0
2022	12	0
2023	22	0
2024	15	0
2025	13	0
2026	12	0

FIG. 1 — Lineage of K914004, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (93)

See all 93

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

Number	Device	Applicant	Decided	Descendants
K110472	SI-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	2012	92

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, K110472 (Medtronic Sofamor Danek, 2012) has gone furthest, with 92 descendants of its own.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

https://510kreport.com/device/K914004 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914004: Alphatec Cannulated Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914004

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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