510(k) · Cleared

Cleared

Luhr Pan Fixation System

K913355510(k) TraditionalCleared Dec 2, 1991126-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 Dec 2, 1991 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 190 later devices descend from it.

Decided: Dec 2, 1991
Review: 126 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

190 later devices descend from it, 2 citing it directly.

This deviceK913355 Luhr Pan Fixation SystemHowmedica Corp. · 1991
Descendant · cites it directly · 188 of its ownK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
Descendant · cites it directly · 144 of its ownK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 143 of its ownK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
Descendant · 3 generations on · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
Descendant · 4 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002

Showing 5 of 190 descendants. See all descendants

Descendants cleared per year

1997high 23 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 190 · See all

K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly188descendants
K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly144descendants
K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997 · 2 generations on143descendants
K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · 3 generations on141descendants
K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 4 generations on117descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913355	Luhr Pan Fixation System	Howmedica Corp.	1991	—
+1	K963741	Leibinger Luhr Small Craniomaxillofacial Bone Screws	Howmedica Leibinger, Inc.	1997	—
+1	K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	1997	—
+2	K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	1997	—
+3	K974785	Auto-Drive Bone Screw	Osteomed Corp.	1998	—
+4	K013954	Lorenz Self Drilling Screws	Walter Lorenz Surgical, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	1	0
1999	1	0
2002	3	0
2003	6	0
2004	1	0
2005	1	0
2006	3	0
2007	3	0
2008	2	0
2009	2	0
2010	5	0
2011	5	0
2012	11	0
2013	7	0
2014	8	0
2015	11	0
2016	10	0
2017	2	0
2018	10	0
2019	7	0
2020	5	0
2021	4	0
2022	8	0
2023	13	0
2024	23	0
2025	17	0
2026	18	0

FIG. 1 — Lineage of K913355, 1991–2026Source: 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? (190)

See all 190

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

Number	Device	Applicant	Decided	Descendants
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, K963741 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 188 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/K913355 · printed Nov 5, 2026

Cite this page

510(k) Report. “K913355: Luhr Pan Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913355

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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