510(k) · Cleared

Cleared

Normed Bone Transport

K990140510(k) TraditionalCleared Mar 25, 199965-day reviewClass II21 CFR 872.4760

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

Ace Surgical Supply Co., Inc. · JEY Plate, Bone

Cleared on Mar 25, 1999 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Mar 25, 1999
Review: 65 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK990140 Normed Bone TransportAce Surgical Supply Co., Inc. · 1999
Descendant · cites it directly · 0 of its ownK021341 Normed Bone Transport Distraction DeviceOsteomedics, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all

K021341Normed Bone Transport Distraction DeviceOsteomedics, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990140	Normed Bone Transport	Ace Surgical Supply Co., Inc.	1999	—
+1	K021341	Normed Bone Transport Distraction Device	Osteomedics, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K990140, 1999–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEY? 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 JEY device

#1 K252246 Leforte MMF Systemscore 15.6 · 16 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K021341	Normed Bone Transport Distraction Device	Osteomedics, Inc.	2002	0

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, K021341 (Osteomedics, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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	9	115	0	29
2008	7	84	3	24
2009	4	121	6	93
2010	6	199	85	215
2011	5	75	0	241
2012	10	194	0	428
2013	8	126	1	766
2014	6	223	0	616
2015	7	160	0	767
2016	1	—	0	558
2017	5	190	0	568
2018	7	255	0	608
2019	6	163	0	595
2020	6	198	1	680
2021	4	299	0	451
2022	5	135	0	344
2023	2	—	0	495
2024	5	159	0	696
2025	2	—	0	1,003
2026	3	258	0	—

What is it indicated for?

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for…

Read the full statement (107 words)

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous

mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As

clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved

with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory

monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Clinical Indications are as follows:

- Tumor Resections

- Severe trauma which make continuous bone segments no longer possible

- Bone grafting defects .

- Severe open mandibular fractures

+ Facial deformity corrections

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990140: Normed Bone Transport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990140

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