510(k) · Cleared

Cleared

Sterling Interferenc Screw HT

K052405510(k) TraditionalCleared Nov 16, 200576-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

Regeneration Technologies, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 16, 2005 after a 76-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.

Decided: Nov 16, 2005
Review: 76 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK052405 Sterling Interferenc Screw HTRegeneration Technologies, Inc. · 2005
Descendant · cites it directly · 65 of its ownK072914 Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008
Descendant · 2 generations on · 53 of its ownK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
Descendant · 2 generations on · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
Descendant · 2 generations on · 38 of its ownK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2008high 8 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 66 · See all

K072914Natural Bridge LP Transverse ConnectorsK2m, Inc. · 2008 · cites it directly65descendants
K120099Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · 2 generations on53descendants
K120656Everest Spinal SystemK2m, Inc. · 2012 · 2 generations on43descendants
K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
K121016Range Spinal System (Mesa and Denali)K2m, Inc. · 2012 · 2 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052405	Sterling Interferenc Screw HT	Regeneration Technologies, Inc.	2005	—
+1	K072914	Natural Bridge LP Transverse Connectors	K2m, Inc.	2008	—
+2	K120099	Range Spinal System (Mesa and Denali)	K2m, Inc.	2012	—
+2	K120656	Everest Spinal System	K2m, Inc.	2012	—
+2	K132757	Everest Spinal System	K2m, Inc.	2013	—
+2	K121016	Range Spinal System (Mesa and Denali)	K2m, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2012	5	0
2013	7	0
2014	6	0
2015	8	0
2016	4	0
2017	7	0
2018	7	0
2020	2	0
2021	1	0
2022	2	0
2023	4	0
2024	7	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K052405, 2005–2026Source: 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.

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? (1)

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
*	—	STERLING® Interference Screw ST Named without a submission number			—

What descends from it? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K072914	Natural Bridge LP Transverse Connectors	K2m, Inc.	2008	65

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, K072914 (K2m, Inc., 2008) has gone furthest, with 65 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	—

What is it indicated for?

The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052405: Sterling Interferenc Screw HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052405

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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