510(k) · Cleared

Cleared

True/Fit Femoral Intramedullary Rod System

K961360510(k) TraditionalCleared Mar 13, 1997338-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

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

Cleared on Mar 13, 1997 as substantially equivalent to K813371 (Howmedica Corp., 1982) and 2 other predicates after a 338-day review. Its family tree reaches back 1 generation to 1982.

Decided: Mar 13, 1997
Review: 338 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K813371 (1982). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK813371 Grosse and Kempf Locking Nail Sys.Howmedica Corp. · 1982
This deviceK961360 True/Fit Femoral Intramedullary Rod SystemEncore Orthopedics, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K813371	Grosse and Kempf Locking Nail Sys.	Howmedica Corp.	1982	—
0 (this device)	K961360	True/Fit Femoral Intramedullary Rod System	Encore Orthopedics, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1992	1	0

FIG. 1 — Lineage of K961360, 1982–1997Source: 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? (3)

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
*	K813371	Grosse and Kempf Locking Nail Sys. Summary page 2 …Inc. TRUE/FIT™ Femoral Intramedullary Rod System 512-206-1437 Ashley M. Bock Page 2 Comparable Features to Predicate Device(s): Gross/Kempf Femoral Nall Howmedica K813371 Russell/Taylor Femoral Nail Richards Medical K893377 Universal Nailing System Synthes K914371	Howmedica Corp.	1982	—
*	K893377	Russell-Taylor Intramedullary Knee Fusion Nails Summary page 2 …206-1437 Ashley M. Bock Page 2 Comparable Features to Predicate Device(s): Gross/Kempf Femoral Nall Howmedica K813371 Russell/Taylor Femoral Nail Richards Medical K893377 Universal Nailing System Synthes K914371	Richards Medical Co., Inc.	1989	—
*	K914371	Universal Femoral Nail Summary page 2 …eatures to Predicate Device(s): Gross/Kempf Femoral Nall Howmedica K813371 Russell/Taylor Femoral Nail Richards Medical K893377 Universal Nailing System Synthes K914371	Synthes (Usa)	1992	—

Also cleared against K813371: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K813371.

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?

TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures:

femoral shaft fractures

high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter)

intertrochanteric femoral fractures

femoral neck fractures

ipsilateral femoral neck and shaft 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/K961360 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961360: True/Fit Femoral Intramedullary Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961360

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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