510(k) · Cleared
ClearedGotfried Physiological Hip (PH) Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Efratgo, Ltd. HI Tech Bio-Surgical · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 1, 2005 as substantially equivalent to K983814 (Efratgo, Ltd. HI Tech Bio-Surgical, 1999) and 2 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Feb 1, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954555 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954555 Versa-FX Femoral Fixation SystemZimmer, Inc. · 1996 · Recalled
- 1 generation backK983814 Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999
- This deviceK043233 Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2005
- Descendant · cites it directly · 0 of its ownK083648 Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2009
Most influential descendants
Showing 1 of 1 · See all- K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954555 | Versa-FX Femoral Fixation System | Zimmer, Inc. | 1996 | 1 |
| −1 | K983814 | Gotfried Percutaneous Compression Plating System | Efratgo, Ltd. HI Tech Bio-Surgical | 1999 | — |
| 0 (this device) | K043233 | Gotfried Physiological Hip (PH) Nail | Efratgo, Ltd. HI Tech Bio-Surgical | 2005 | — |
| +1 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K983814 | Gotfried Percutaneous Compression Plating SystemSummary page 1…gical Hip) Nail Classification Device: Fixation, Proximal, Femoral Implant Name: 3. Predicate Gotfried Percutaneous Compression Plating System K983814 Devices: Synthes PFN Proximal Femoral Nail K970097 Howmedica (Stryker) Gamma Locking Nail… | 1999 |
| * | K970097 | Proximal Femoral Nail (PFN) SystemSummary page 1…, Femoral Implant Name: 3. Predicate Gotfried Percutaneous Compression Plating System K983814 Devices: Synthes PFN Proximal Femoral Nail K970097 Howmedica (Stryker) Gamma Locking Nail K034002 4. Description: The Gotfried PH (Physiological H… | 1997 |
| * | K034002 | GAMMA3 Nail SystemSummary page 1…neous Compression Plating System K983814 Devices: Synthes PFN Proximal Femoral Nail K970097 Howmedica (Stryker) Gamma Locking Nail K034002 4. Description: The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utili… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083648 | Gotfried Physiological Hip (PH) Nail | 2009 | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K083648 (Efratgo, Ltd. HI Tech Bio-Surgical, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K983814.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 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, and base of neck fractures of the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043233: 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/K043233
Report an extraction error
Are you the manufacturer?
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