510(k) · Cleared

Recalled · 2009

Titanium Pediatric Femoral Nail

K993956510(k) SpecialCleared Dec 20, 199928-day reviewClass II21 CFR 888.3020Recalls 11

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

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

Cleared on Dec 20, 1999 as substantially equivalent to K982953 (Biomet, Inc., 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998. 14 later devices descend from it. It has been recalled 11 times.

Decided: Dec 20, 1999
Review: 28 days
Class: Class II
Product code: HSB
Recalls: 11
Predicates: 1

Its longest line of descent runs back 1 generation to K982953 (1998). 14 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
This deviceK993956 Titanium Pediatric Femoral NailBiomet, Inc. · 1999
Descendant · cites it directly · 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 · cites it directly · 6 of its ownK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
Descendant · 2 generations on · 4 of its ownK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009high 3 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 14 · See all

K111232Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · cites it directly7descendants
K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · 2 generations on6descendants
K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · cites it directly6descendants
K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · 2 generations on4descendants
K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982953	Titanium Intramedullary Nails-Various Styles	Biomet, Inc.	1998	4
0 (this device)	K993956	Titanium Pediatric Femoral Nail	Biomet, Inc.	1999	—
+1	K111232	Gap Endo-Exo Medullary System	Pega Medical, Inc.	2012	1
+2	K160545	Gap Endo-Exo Medullary System	Pega Medical, Inc.	2016	—
+1	K083726	Pedinail Intramedullary Nailing System	OrthoPediatrics Corp.	2009	27
+2	K172583	OrthoPediatrics PediNail Intramedullary Platform	Orthopediatrics, Inc.	2018	3
+3	K250163	T2 Alpha Femur Retrograde Nailing System	Stryker GmbH	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2013	1	0
2016	1	0
2018	2	0
2019	1	0
2022	1	0
2023	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K993956, 1998–2026Source: 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

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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
*	K982953	Titanium Intramedullary Nails-Various Styles Summary page 2 …n of long bones since the 1960’s. In addition, a wide variety of titanium intramedullary rods (nails) were cleared for commercial distribution under Biomet 510(k) number K982953 for use in the femur, tibia, fibula, humerus, radius, and ulna. Biomet/OEC Stainless Steel Flexible Nails Biomet Titanium Intram…	Biomet, Inc.	1998	4
*	—	Biomet/OEC Stainless Steel Flexible Nails Named without a submission number			—

Also cleared against K982953: 11 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K111232	Gap Endo-Exo Medullary System	Pega Medical, Inc.	2012	7
K083726	Pedinail Intramedullary Nailing System	OrthoPediatrics Corp.	2009	6
K122823	Sign Pediatric Fin Nail	Sign Fracture Care International	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 2, 2009	Not classified	Z-2311-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2307-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2312-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2308-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2306-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2310-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2305-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2303-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2302-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2309-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2304-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K111232 (Pega Medical, Inc., 2012) has gone furthest, with 7 descendants of its own.
11 other devices also cite its predicate K982953.

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 Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric 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/K993956 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993956: Titanium Pediatric Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993956

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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