510(k) · Cleared

Cleared

Lorenz Small Fragment System

K992961510(k) TraditionalCleared Nov 8, 199967-day reviewClass II21 CFR 888.3030

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. · HRS Plate, Fixation, Bone

Cleared on Nov 8, 1999 after a 67-day review. The FDA summary names no predicate by number. 378 later devices descend from it.

Decided: Nov 8, 1999
Review: 67 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

378 later devices descend from it, 3 citing it directly.

This deviceK992961 Lorenz Small Fragment SystemWalter Lorenz Surgical, Inc. · 1999
Descendant · cites it directly · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
Descendant · 2 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
Descendant · 3 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
Descendant · 4 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010

Showing 5 of 378 descendants. See all descendants

Descendants cleared per year

2002high 41 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 378 · See all

K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · cites it directly360descendants
K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 2 generations on343descendants
K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 3 generations on342descendants
K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 4 generations on339descendants
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992961	Lorenz Small Fragment System	Walter Lorenz Surgical, Inc.	1999	—
+1	K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	—
+2	K050868	Maxlock	Orthohelix Surgical Designs, Inc.	2005	—
+3	K073624	Modular Foot System	Orthohelix Surgical Designs, Inc.	2008	1
+4	K100618	Maxlock Extreme Extremity Plating System with Variable Angle Technology	Orthohelix Surgical Designs, Inc.	2010	—
+4	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	3	0
2008	1	0
2010	4	0
2011	2	0
2012	14	0
2013	10	0
2014	16	0
2015	26	0
2016	15	0
2017	33	0
2018	17	0
2019	22	0
2020	29	0
2021	24	0
2022	24	0
2023	31	0
2024	41	0
2025	26	0
2026	38	0

FIG. 1 — Lineage of K992961, 1999–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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?

The FDA summary names no predicate by number.

What descends from it? (378)

See all 378

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040598	KLS Martin Hand Plating System	KLS-Martin L.P.	2004	360
K023360	Leforte System Bone Plate	Jeil Medical Corporation	2002	20
K051162	Generos SB Small Bone Distraction Implant	Orthonetx, Inc.	2005	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, K040598 (KLS-Martin L.P., 2004) has gone furthest, with 360 descendants of its own.

How does its category compare?

All HRS devices

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

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.

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/K992961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992961: Lorenz Small Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992961

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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