510(k) · Cleared

Cleared

Medicon Imf-Orion Screws

K050478510(k) TraditionalCleared Jun 15, 2005111-day reviewClass II21 CFR 872.3640

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

Medicon EG · DZE Implant, Endosseous, Root-Form

Cleared on Jun 15, 2005 as substantially equivalent to K010527 (Synthes (Usa), 2001) and 3 other predicates after a 111-day review. Its family tree reaches back 3 generations to 1982.

Decided: Jun 15, 2005
Review: 111 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K820944 (1982). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
2 generations backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
1 generation backK983728 Lorenz Imf ScrewWalter Lorenz Surgical, Inc. · 1999
This deviceK050478 Medicon Imf-Orion ScrewsMedicon EG · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K820944	Dental Arch Bar	Unisplint Corp.	1982	—
−2	K963030	Leibinger Imf Screw	Howmedica Leibinger, Inc.	1997	—
−1	K983728	Lorenz Imf Screw	Walter Lorenz Surgical, Inc.	1999	—
0 (this device)	K050478	Medicon Imf-Orion Screws	Medicon EG	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	1	0
1999	1	0
2001	1	0

FIG. 1 — Lineage of K050478, 1982–2005Source: 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 DZE? 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 DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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
*	K010527	Synthes (Usa) Imf Screws Summary page 1 …[807.81(2)] New Device 2.5 Predicate Device [807.92(a)(3)] Manufacturer Synthes (USA); Paoli. K010527 Proprietary Name Synthes (USA) IMF Screws Catalogue #'s "IMF Screw Set" GP1852-B…	Synthes (Usa)	2001	—
*	K983728	Lorenz Imf Screw Summary page 1 …"IMF Screw Set" GP1852-B see exhibit 4a Manufacturer Walter Lorenz Surgical, Inc. K983728 Proprietary Name Lorenz IMF Screws Catalogue #'s <<2.0/2.4 MANDIBULAR FRACTURE SYSTEM >»…	Walter Lorenz Surgical, Inc.	1999	—
*	K980760	KLS-Martin MMF Screw Summary page 1 …00-2117, p. 4 see exhibit 4b Manufacturer KLS-Martin L.P. K980760 Proprietary Name KLS-Martin MMF Screw Catalogue #'s <<FAST-FIX IMF-SYSTEM > 90-848-02…	KLS-Martin L.P.	1999	—
*	K963030	Leibinger Imf Screw Summary page 1 …T-FIX IMF-SYSTEM > 90-848-02 see exhibit 4c Manufacturer Howmedica Leibinger, Inc. K963030 Proprietary Name Leibinger IMF Screws Catalogue #'s (<IMF Screw System for Intermaxillary Fixa…	Howmedica Leibinger, Inc.	1997	—

Also cleared against K010527: 2 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?

The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
None of the 7 ancestors has a recall.
2 other devices also cite its predicate K010527.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

The Medicon IMF Orion Screws are intended for use as a

bone screw in temporary fixation of the maxilla and mandible, providing indirect

stabilization of fractures of the maxilla, martdible or both.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050478 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050478: Medicon Imf-Orion Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050478

Report an extraction error

Are you the manufacturer?

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