510(k) · Cleared

Cleared

Grosse and Kempf Locking Nail Sys.

K813371510(k) TraditionalCleared Mar 1, 198291-day reviewClass II21 CFR 888.3020

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

Howmedica Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 1, 1982 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Mar 1, 1982
Review: 91 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 0

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

This deviceK813371 Grosse and Kempf Locking Nail Sys.Howmedica Corp. · 1982
Descendant · cites it directly · 15 of its ownK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
Descendant · 2 generations on · 14 of its ownK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled
Descendant · 2 generations on · 7 of its ownK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · Recalled
Descendant · 2 generations on · 6 of its ownK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
Descendant · 3 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1996high 4 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 20 · See all

K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · cites it directly15descendants
K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · 2 generations on14descendants
K111232Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · 2 generations on7descendants
K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · 2 generations on6descendants
K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K813371	Grosse and Kempf Locking Nail Sys.	Howmedica Corp.	1982	—
+1	K020885	Fassire-Duval Telescopic IM System	Pega Medical, Inc.	2003	4
+2	K041393	Fassier-Duval Telscopic IM System	Pega Medical, Inc.	2004	5
+2	K111232	Gap Endo-Exo Medullary System	Pega Medical, Inc.	2012	1
+2	K160545	Gap Endo-Exo Medullary System	Pega Medical, Inc.	2016	—
+3	K143355	The Simple Locking IntraMedullary (SLIM) System	Pega Medical, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
2003	1	0
2004	1	0
2012	1	0
2015	1	0
2016	1	0
2020	1	0
2021	1	0
2023	1	0
2024	1	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K813371, 1982–2026Source: 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 HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 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? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K020885	Fassire-Duval Telescopic IM System	Pega Medical, Inc.	2003	15
K960524	Alta CFX IM Rod System	Howmedica Corp.	1996	2
K961360	True/Fit Femoral Intramedullary Rod System	Encore Orthopedics, Inc.	1997	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, K020885 (Pega Medical, Inc., 2003) has gone furthest, with 15 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

https://510kreport.com/device/K813371 · printed Nov 6, 2026

Cite this page

510(k) Report. “K813371: Grosse and Kempf Locking Nail Sys..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813371

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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