510(k) · Cleared

Cleared

Gotfried Physiological Hip (PH) Nail

K083648510(k) TraditionalCleared May 14, 2009156-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

Efratgo, Ltd. HI Tech Bio-Surgical · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 14, 2009 as substantially equivalent to K040656 (Smith & Nephew, Inc., 2004) and 2 other predicates after a 156-day review. Its family tree reaches back 3 generations to 1998.

Decided: May 14, 2009
Review: 156 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K981529 (1998). 16 ancestors in all, the oldest K954712 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
2 generations backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
1 generation backK040656 Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004
This deviceK083648 Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K981529	Titanium Intramedullary Nail, Titanium Locking Screw	Smith & Nephew, Inc.	1998	2
−2	K040212	Trigen Intertan	Smith & Nephew, Inc.	2004	6
−1	K040656	Modification to Smith & Nephew Intramedullary Hip Screw	Smith & Nephew, Inc.	2004	—
0 (this device)	K083648	Gotfried Physiological Hip (PH) Nail	Efratgo, Ltd. HI Tech Bio-Surgical	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0
1998	1	0
1999	2	0
2001	3	0
2003	1	0
2004	1	0
2005	2	0

FIG. 1 — Lineage of K083648, 1998–2009Source: 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
*	K040656	Modification to Smith & Nephew Intramedullary Hip Screw Summary page 1 …evice & Gotfried PH (Physiological Hip) Nail Classification Device: Rod, Fixation, Intramedullary, and Accessories Name: 3. Predicate K040656- Smith & Nephew Intramedullary Hip Screw Devices: K043431- Stryker Gamma3 Locking Nail K04…	Smith & Nephew, Inc.	2004	—
*	K043431	GAMMA3 Nail System Summary page 1 …n Device: Rod, Fixation, Intramedullary, and Accessories Name: 3. Predicate K040656- Smith & Nephew Intramedullary Hip Screw Devices: K043431- Stryker Gamma3 Locking Nail K043233- Gotfried Physiological Hip (PH) Nail 4. Description: The G…	Howmedica Osteonics Corp.	2005	—
*	K043233	Gotfried Physiological Hip (PH) Nail Summary page 1 …Name: 3. Predicate K040656- Smith & Nephew Intramedullary Hip Screw Devices: K043431- Stryker Gamma3 Locking Nail K043233- Gotfried Physiological Hip (PH) Nail 4. Description: The Gotfried PH (Physiological Hip) Nail is an intramedullary…	Efratgo, Ltd. HI Tech Bio-Surgical	2005	—

Also cleared against K040656: 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?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
7 of the 16 ancestors have a recall of any class.
2 other devices also cite its predicate K040656.

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. 2009, 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 Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083648: Gotfried Physiological Hip (PH) Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083648

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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