510(k) · Cleared

Cleared

Titanium Retrograde Femoral Nail - 13 MM Diameter

K013923510(k) TraditionalCleared Feb 25, 200290-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

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

Cleared on Feb 25, 2002 as substantially equivalent to K982953 (Biomet, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Feb 25, 2002
Review: 90 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982953 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
This deviceK013923 Titanium Retrograde Femoral Nail - 13 MM DiameterBiomet Orthopedics, Inc. · 2002
Descendant · cites it directly · 0 of its ownK021782 BNFAap Implantate AG · 2002

Most influential descendants

Showing 1 of 1 · See all

K021782BNFAap Implantate AG · 2002 · cites it directly0descendants

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)	K013923	Titanium Retrograde Femoral Nail - 13 MM Diameter	Biomet Orthopedics, Inc.	2002	—
+1	K021782	BNF	Aap Implantate AG	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K013923, 1998–2002Source: 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? (1)

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 1 …ly Marketed Devices to Which Substantial Equivalence Is Claimed: These devices are substantially equivalent to Biomet Titanium Intramedullary Nails previously cleared in K982953. Device Description: Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedull…	Biomet, Inc.	1998	4

Also cleared against K982953: 11 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021782	BNF	Aap Implantate AG	2002	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?

Its one ancestor has a recall.
Of its descendants, K021782 (Aap Implantate AG, 2002) has gone furthest, with 0 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?

Femoral nails are to be used for treatment of fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the head and femoral neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. Other indications include: osteotomy and reconstructive procedures following tumor resection, and revision procedures where other treatments or devices have failed.

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/K013923 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013923: Titanium Retrograde Femoral Nail - 13 MM Diameter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013923

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026