510(k) · Cleared

Recalled · Class II · 2013

Supracondylar Intramedullary Nail

K962561510(k) TraditionalCleared Sep 25, 199686-day reviewClass II21 CFR 888.3020Recalls 1

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

Zimmer, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 25, 1996 after an 86-day review. The FDA summary names its predicate without a number. 77 later devices descend from it. It has been recalled once.

Decided: Sep 25, 1996
Review: 86 days
Class: Class II
Product code: HSB
Recalls: 1
Predicates: 0

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

This deviceK962561 Supracondylar Intramedullary NailZimmer, Inc. · 1996
Descendant · cites it directly · 75 of its ownK965098 Intramedullary Nail SystemZimmer, Inc. · 1997 · Recalled
Descendant · 2 generations on · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
Descendant · 2 generations on · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
Descendant · cites it directly · 29 of its ownK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
Descendant · 3 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

1997high 8 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 77 · See all

K965098Intramedullary Nail SystemZimmer, Inc. · 1997 · cites it directly75descendants
K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · 2 generations on39descendants
K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · 2 generations on35descendants
K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · cites it directly29descendants
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 3 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962561	Supracondylar Intramedullary Nail	Zimmer, Inc.	1996	—
+1	K965098	Intramedullary Nail System	Zimmer, Inc.	1997	29
+2	K083497	Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…	Zimmer, Inc.	2009	16
+2	K082770	Zimmer Natural Nail System Tibial Nail	Zimmer, Inc.	2008	15
+1	K101622	Zimmer Natural Nail System Retrograde Femoral Nails	Zimmer, Inc.	2010	3
+3	K172774	T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…	Stryker Trauma GmbH	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	1	0
2008	1	0
2009	3	0
2010	1	0
2011	1	0
2012	1	0
2013	3	0
2014	4	0
2015	2	0
2016	1	0
2017	6	0
2018	6	0
2019	7	0
2020	6	0
2021	3	0
2022	5	0
2023	6	0
2024	4	0
2025	8	0
2026	7	0

FIG. 1 — Lineage of K962561, 1996–2026Source: 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 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	—	Intramedullary Supracondylar Nail Named without a submission number			—
*	—	AIM Supracondylar Nail Named without a submission number			—

What descends from it? (77)

See all 77

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

Number	Device	Applicant	Decided	Descendants
K965098	Intramedullary Nail System	Zimmer, Inc.	1997	75
K101622	Zimmer Natural Nail System Retrograde Femoral Nails	Zimmer, Inc.	2010	29
K142281	Zimmer M/DN Intramedullary Fixation System	Zimmer, Inc.	2014	10

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 11, 2013	Class II	Z-1008-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K965098 (Zimmer, Inc., 1997) has gone furthest, with 75 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	—

What is it indicated for?

The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.

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/K962561 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962561: Supracondylar Intramedullary Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962561

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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