510(k) · Cleared

Cleared

Alphatec 2.7 MM Cannulated Cortical Lag Screw

K923256510(k) TraditionalCleared Oct 9, 199299-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 Oct 9, 1992 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 242 later devices descend from it.

Decided: Oct 9, 1992
Review: 99 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK923256 Alphatec 2.7 MM Cannulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
Descendant · cites it directly · 241 of its ownK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
Descendant · 2 generations on · 171 of its ownK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
Descendant · 3 generations on · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
Descendant · 4 generations on · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
Descendant · 5 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled

Showing 5 of 242 descendants. See all descendants

Descendants cleared per year

2001high 33 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 242 · See all

K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001 · cites it directly241descendants
K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003 · 2 generations on171descendants
K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · 3 generations on168descendants
K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · 4 generations on143descendants
K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 5 generations on142descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923256	Alphatec 2.7 MM Cannulated Cortical Lag Screw	Alphatec Mfg., Inc.	1992	—
+1	K013534	Self-Countersinking Bone Screw	Biomet Orthopedics, Inc.	2001	—
+2	K024086	Propeller Head Small Cannulated Screw System	Biomet Orthopedics, Inc.	2003	—
+3	K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	—
+4	K093629	Solitaire and Solitaire Peek Anterior Spinal System	Biomet Spine	2010	1
+5	K113796	Solitaire-C Cervical Spacer System	Ebi, LLC	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2009	3	0
2010	1	0
2012	2	0
2013	4	0
2014	5	0
2015	9	0
2016	6	0
2017	15	0
2018	3	0
2019	5	0
2020	13	0
2021	19	0
2022	28	0
2023	33	0
2024	31	0
2025	31	0
2026	31	0

FIG. 1 — Lineage of K923256, 1992–2026Source: 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? (242)

See all 242

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

Number	Device	Applicant	Decided	Descendants
K013534	Self-Countersinking Bone Screw	Biomet Orthopedics, Inc.	2001	241

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, K013534 (Biomet Orthopedics, Inc., 2001) has gone furthest, with 241 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/K923256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923256: Alphatec 2.7 MM Cannulated Cortical Lag Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923256

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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