510(k) · Cleared

Cleared

Luhr Mini Bone Screw and Z Plate

K935448510(k) TraditionalCleared Feb 23, 1994103-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

Howmedica Corp. · HRS Plate, Fixation, Bone

Cleared on Feb 23, 1994 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 469 later devices descend from it.

Decided: Feb 23, 1994
Review: 103 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

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

This deviceK935448 Luhr Mini Bone Screw and Z PlateHowmedica Corp. · 1994
Descendant · cites it directly · 280 of its ownK021626 Hallu PlatesNew Deal, S.A. · 2002
Descendant · 2 generations on · 249 of its ownK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
Descendant · 3 generations on · 245 of its ownK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
Descendant · 4 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
Descendant · cites it directly · 188 of its ownK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997

Showing 5 of 469 descendants. See all descendants

Descendants cleared per year

1997high 54 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 469 · See all

K021626Hallu PlatesNew Deal, S.A. · 2002 · cites it directly280descendants
K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004 · 2 generations on249descendants
K052614Low Profile Plate and Screw SystemArthrex, Inc. · 2005 · 3 generations on245descendants
K103705Low Profile ScrewsArthrex, Inc. · 2011 · 4 generations on219descendants
K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly188descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935448	Luhr Mini Bone Screw and Z Plate	Howmedica Corp.	1994	—
+1	K021626	Hallu Plates	New Deal, S.A.	2002	—
+2	K040907	Arthrex Small Fragment Plates and Screws	Arthrex, Inc.	2004	—
+3	K052614	Low Profile Plate and Screw System	Arthrex, Inc.	2005	—
+4	K103705	Low Profile Screws	Arthrex, Inc.	2011	—
+1	K963741	Leibinger Luhr Small Craniomaxillofacial Bone Screws	Howmedica Leibinger, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	1	0
1999	1	0
2002	4	0
2003	6	0
2004	2	0
2005	5	0
2006	3	0
2007	4	0
2008	2	0
2009	4	0
2010	6	0
2011	11	0
2012	15	0
2013	15	0
2014	17	0
2015	28	0
2016	15	0
2017	30	0
2018	18	0
2019	22	0
2020	26	0
2021	22	0
2022	25	0
2023	37	0
2024	50	0
2025	43	0
2026	54	0

FIG. 1 — Lineage of K935448, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (469)

See all 469

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

Number	Device	Applicant	Decided	Descendants
K021626	Hallu Plates	New Deal, S.A.	2002	280
K963741	Leibinger Luhr Small Craniomaxillofacial Bone Screws	Howmedica Leibinger, Inc.	1997	188
K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	1997	144

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, K021626 (New Deal, S.A., 2002) has gone furthest, with 280 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	—

https://510kreport.com/device/K935448 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935448: Luhr Mini Bone Screw and Z Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935448

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026