510(k) · Cleared

Cleared

S-Wire

K152662510(k) TraditionalCleared Mar 9, 2016174-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

Spinal Resources, Inc. · HTY Pin, Fixation, Smooth

Cleared on Mar 9, 2016 as substantially equivalent to K060654 (Delta Surgical Instruments, Inc., 2006) after a 174-day review. Its family tree reaches back 1 generation to 2006.

Decided: Mar 9, 2016
Review: 174 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K060654 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK060654 Dsi Pins and WiresDelta Surgical Instruments, Inc. · 2006
This deviceK152662 S-WireSpinal Resources, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K060654	Dsi Pins and Wires	Delta Surgical Instruments, Inc.	2006	—
0 (this device)	K152662	S-Wire	Spinal Resources, Inc.	2016	—

FIG. 1 — Lineage of K152662, 2006–2016Source: 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 HTY? 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 HTY device

#1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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
*	K060654	Dsi Pins and Wires Summary page 4 …ice 510k Trade or Proprietary or Manufacturer Predicate Number Model Name Type K060654 DSI Pins and Wires Delta Surgical Instruments Primary CONCLUSION The overall technology characteristics and…	Delta Surgical Instruments, Inc.	2006	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · HTY

5in 2025

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

What is it indicated for?

The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152662: S-Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152662

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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