510(k) · Cleared

Recalled · Class II · 2024

DePuy Synthes TFNA Augmentation System

K160167510(k) TraditionalCleared Sep 26, 2016243-day reviewClass II21 CFR 888.3020Recalls 2

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

Synthes (USA) Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 26, 2016 as substantially equivalent to K961213 (Howmedica Corp., 1996) after a 243-day review. Its family tree reaches back 1 generation to 1996. It has been recalled 2 times.

Decided: Sep 26, 2016
Review: 243 days
Class: Class II
Product code: HSB
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K961213 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK961213 Alta Dome and Plunger (Mec Hip Bolt)Howmedica Corp. · 1996
This deviceK160167 DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961213	Alta Dome and Plunger (Mec Hip Bolt)	Howmedica Corp.	1996	—
0 (this device)	K160167	DePuy Synthes TFNA Augmentation System	Synthes (USA) Products, LLC	2016	—

FIG. 1 — Lineage of K160167, 1996–2016Source: 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
*	K961213	Alta Dome and Plunger (Mec Hip Bolt) Summary page 4 …hes TFNA Augmentation System Name: Classification: Classification: 888.3020, 888.3030 Product Code: HSB, KTT Predicate Alta Dome and Plunger (K961213) Device: Reference DePuy Synthes TFNA System (K131548) Device: Device The DePuy Synthes TFNA Augmentation Sys…	Howmedica Corp.	1996	—
†	K131548	Synthes Trochanteric Fixation Nail - Advanced System	Synthes (USA) Products, LLC	2014	9

Also cleared against K961213: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 24, 2024	Class II	Z-1239-2024	Process control	Products not sterilized, sterility cannot be confirmed
Jan 24, 2024	Class II	Z-1240-2024	Process control	Products not sterilized, sterility cannot be confirmed

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K961213.

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. 2016, this device’s year, is highlighted.

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 Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically the system is indicated for: • Stable and unstable pertrochanteric fractures • Intertrochanteric fractures • Basal neck fractures • Combinations of pertrochanteric, intertrochanteric, and basal neck fractures The Long Nail is additionally intended for treatment of…

Read the full statement (162 words)

The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Specifically the system is indicated for:

• Stable and unstable pertrochanteric fractures

• Intertrochanteric fractures

• Basal neck fractures

• Combinations of pertrochanteric, intertrochanteric, and basal neck fractures

The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12- 21) in which the growth plates have fused for the following indications:

• Subtrochanteric fractures

• Pertrochanteric fractures associated with shaft fractures

• Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions

• Long Subtrochanteric fractures

• Proximal or distal non-unions, malunions and revisions

Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160167 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160167: DePuy Synthes TFNA Augmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160167

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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