510(k) · Cleared

Cleared

Lorenz Resorbable Distraction System or Expander

K030425510(k) TraditionalCleared May 14, 2004459-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

Walter Lorenz Surgical, Inc. · JEY Plate, Bone

Cleared on May 14, 2004 as substantially equivalent to K002083 (Walter Lorenz Surgical, Inc., 2001) and 5 other predicates after a 459-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: May 14, 2004
Review: 459 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K955729 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955729 Lactosorb Trauma Plating SystemPoly-Medics,Inc. · 1996 · Recalled
This deviceK030425 Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK133304 RXG Distraction SystemKLS-Martin L.P. · 2014

Most influential descendants

Showing 1 of 1 · See all

K133304RXG Distraction SystemKLS-Martin L.P. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955729	Lactosorb Trauma Plating System	Poly-Medics,Inc.	1996	1
0 (this device)	K030425	Lorenz Resorbable Distraction System or Expander	Walter Lorenz Surgical, Inc.	2004	—
+1	K133304	RXG Distraction System	KLS-Martin L.P.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
1999	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K030425, 1996–2014Source: 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 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

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What was it cleared against? (6)

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
*	K002083	Lorenz Resorbable Distractor System Summary page 1 …, Bone (21 CFR 888.3040) Product Code: 76 JEY Device Classification: Class II (K002083). This device is composed of the This distractor system is identical to the one cleared in 510(k) Premarket Notification…	Walter Lorenz Surgical, Inc.	2001	3
*	K992952	Lorenz Distraction System Summary page 2 …and pain which may not be related to the implant. Substantial Equivalence Distraction Systems Lorenz Resorbable Distractor System (K002083) Lorenz Distraction System (K992952) Resorbable Fixation Screws and Plates Lactosorb® Trauma Plating System (K971870) Lactosorb® Trauma Plating System (K955729) 2.5…	Walter Lorenz Surgical, Inc.	1999	—
*	K971870	Lactosorb Trauma Plating System Summary page 1 …s These hydrolytic products are then further degraded into carbon dioxide use in bone plates (K992355, K992158, K971870, K960988, K955729) and been previously cleared by 510(k) notifications for bone screws (K981666, K960988) for cranial and maxil…	Biomet, Inc.	1997	—
*	K955729	Lactosorb Trauma Plating System Summary page 1 …c products are then further degraded into carbon dioxide use in bone plates (K992355, K992158, K971870, K960988, K955729) and been previously cleared by 510(k) notifications for bone screws (K981666, K960988) for cranial and maxillofacial use.…	Poly-Medics,Inc.	1996	1
*	K981666	2.5 MM Lactosorb Screws Summary page 1 …use in bone plates (K992355, K992158, K971870, K960988, K955729) and been previously cleared by 510(k) notifications for bone screws (K981666, K960988) for cranial and maxillofacial use.…	Biomet, Inc.	1998	—
*	K974309	Lactosorb Panels Summary page 2 …le Fixation Screws and Plates Lactosorb® Trauma Plating System (K971870) Lactosorb® Trauma Plating System (K955729) 2.5 MM Lactosorb® Screws (K981666) Lactosorb® Panels (K974309) RELATED ARTICLES: 1. Burstein MD, Fernando D., Williams MD, Joseph K., Hudgins MD, Roger, Graham MD, Leroy, Teague MD, Ge…	Biomet, Inc.	1998	—

Also cleared against K002083: 2 other devices →

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
K133304	RXG Distraction System	KLS-Martin L.P.	2014	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?

2 of the 6 ancestors have a recall of any class.
Of its descendants, K133304 (KLS-Martin L.P., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K002083.

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 Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) when correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone distraction. The Lorenz Resorbable Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of mandibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030425: Lorenz Resorbable Distraction System or Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030425

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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