510(k) · Cleared

Cleared

Acid Etched Lag Screws

K070955510(k) TraditionalCleared Oct 12, 2007190-day reviewClass II21 CFR 888.3020

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

Biomet Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Oct 12, 2007 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 188 later devices descend from it.

Decided: Oct 12, 2007
Review: 190 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 0

188 later devices descend from it, 3 citing it directly.

This deviceK070955 Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
Descendant · cites it directly · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
Descendant · cites it directly · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
Descendant · 2 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
Descendant · 3 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
Descendant · 4 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019

Showing 5 of 188 descendants. See all descendants

Descendants cleared per year

2008high 28 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 188 · See all

K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · cites it directly168descendants
K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · cites it directly143descendants
K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 2 generations on142descendants
K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 3 generations on108descendants
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 4 generations on93descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K070955	Acid Etched Lag Screws	Biomet Orthopedics, Inc.	2007	—
+1	K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	—
+1	K093629	Solitaire and Solitaire Peek Anterior Spinal System	Biomet Spine	2010	1
+2	K113796	Solitaire-C Cervical Spacer System	Ebi, LLC	2012	1
+3	K132029	Vault-C Intervertebral Body Fusion Device	Spinal USA	2013	—
+4	K190546	NEXXT MATRIXX Stand Alone Cervical System	Nexxt Spine, LLC	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2012	3	0
2013	4	0
2014	3	0
2015	3	0
2016	4	0
2017	8	0
2018	3	0
2019	5	0
2020	11	0
2021	15	0
2022	25	0
2023	25	0
2024	24	0
2025	28	0
2026	24	0

FIG. 1 — Lineage of K070955, 2007–2026Source: 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 HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (188)

See all 188

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

Number	Device	Applicant	Decided	Descendants
K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	168
K093629	Solitaire and Solitaire Peek Anterior Spinal System	Biomet Spine	2010	143
K081243	Biomet Phoenix Ankle Nail System	Biomet Trauma	2008	18

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, K082874 (Biomet Trauma, 2009) has gone furthest, with 168 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

https://510kreport.com/device/K070955 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070955: Acid Etched Lag Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070955

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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