510(k) · Cleared

Recalled · Class II · 2019

Ebi Xfix Dynafix System HA Coated Screws

K992367510(k) TraditionalCleared Sep 23, 199970-day reviewClass II21 CFR 888.3040Recalls 2

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

Electro-Biology, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 23, 1999 after a 70-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.

Decided: Sep 23, 1999
Review: 70 days
Class: Class II
Product code: HWC
Recalls: 2
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K992367Source: FDA 510(k) database · 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
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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
*	—	Orthofix® External Fixation Screw with Hydroxapatite Coating-Orthofix Srl Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2019	Class II	Z-0528-2020	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Apr 1, 2016	Class II	Z-1823-2016	Equipment maintenance	Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…

No ancestor or descendant has a Class I recall.

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 EBI X FIX DynaFix® Hydroxyapatite® (HA) Coated Screws are intended for use in

external fixation for the treatment of bone conditions including limb lengthening,

corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar

correction and other bone conditions amenable to treatment by use of the external

fixation modality.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992367 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992367: Ebi Xfix Dynafix System HA Coated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992367

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026