510(k) · Cleared

Cleared

Ensplint TM Bone Screw

K080778510(k) TraditionalCleared Jul 10, 2008113-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

Sonoma Orthopedic Products, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 10, 2008 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) after a 113-day review. Its family tree reaches back 1 generation to 1998.

Decided: Jul 10, 2008
Review: 113 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983495 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
This deviceK080778 Ensplint TM Bone ScrewSonoma Orthopedic Products, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…	Syntec Scientific Corp.	1998	—
0 (this device)	K080778	Ensplint TM Bone Screw	Sonoma Orthopedic Products, Inc.	2008	—

FIG. 1 — Lineage of K080778, 1998–2008Source: 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
*	K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120… Summary page 1 …Smooth or threaded metallic bone fixation fastener Predicate Device: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants. K983495, cleared 12/16/1998 Device Description: HA Cortical Self-Tapping Bone Screws in diameters of…	Syntec Scientific Corp.	1998	—

Also cleared against K983495: 10 other devices →

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.
10 other devices also cite its predicate K983495.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 EnsplintTM Bone Screws are intended to treat fractures of various small and long bones. The Ensplintrm Bone Screws can also be used with the EnsplintRx Distal Radius System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080778: Ensplint TM Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080778

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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