510(k) · Cleared

Cleared

Gotfried Percutaneous Compression Plating System

K983814510(k) TraditionalCleared Jan 14, 199978-day reviewClass II21 CFR 888.3030

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 · JDO Device, Fixation, Proximal Femoral, Implant

Cleared on Jan 14, 1999 as substantially equivalent to K970097 (Synthes (Usa), 1997) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1996. 71 later devices descend from it.

Decided: Jan 14, 1999
Review: 78 days
Class: Class II
Product code: JDO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K954555 (1996). 2 ancestors in all. 71 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK954555 Versa-FX Femoral Fixation SystemZimmer, Inc. · 1996 · Recalled
This deviceK983814 Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999
Descendant · cites it directly · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
Descendant · 2 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Descendant · cites it directly · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

2003high 8 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 71 · See all

K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · cites it directly35descendants
K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 2 generations on34descendants
K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954555	Versa-FX Femoral Fixation System	Zimmer, Inc.	1996	1
0 (this device)	K983814	Gotfried Percutaneous Compression Plating System	Efratgo, Ltd. HI Tech Bio-Surgical	1999	—
+1	K080434	Intertan CHS Locking Plate System Prox Fem Plates/Screw	Smith & Nephew, Inc.	2008	—
+2	K090656	Intertan CHS Limited Collapse Set Screw	Smith & Nephew, Inc.	2009	—
+2	K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	2013	—
+3	K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2
+1	K031401	Fixion Dynamic Hip Screw System (Fixion DHS)	Disco-O-Tech Medical Technologies, Ltd.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2008	1	0
2009	2	0
2010	2	0
2011	3	0
2012	1	0
2013	5	0
2014	1	0
2015	2	0
2016	3	0
2017	5	0
2018	4	0
2019	3	0
2020	4	0
2021	3	0
2022	5	0
2023	4	0
2024	8	0
2025	8	0
2026	5	0

FIG. 1 — Lineage of K983814, 1996–2026Source: 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 JDO? 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 JDO device

#1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 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? (2)

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
*	K970097	Proximal Femoral Nail (PFN) System Summary page 2 …ws (length ranging from 31 to 43 mm). Substantial Equivalence: The GOTFRIED PC.CP is substantially equivalent to the Synthes Proximal Femoral Nail (PFN), cleared under K970097, and the Zimmer Versa-Fx Femoral Fixation System, cleared under K954555, in terms of intended use, material and design. Moreover,…	Synthes (Usa)	1997	—
*	K954555	Versa-FX Femoral Fixation System Summary page 2 …FRIED PC.CP is substantially equivalent to the Synthes Proximal Femoral Nail (PFN), cleared under K970097, and the Zimmer Versa-Fx Femoral Fixation System, cleared under K954555, in terms of intended use, material and design. Moreover, based on biomechanical test results, the biomechanical characteristic o…	Zimmer, Inc.	1996	1

Also cleared against K970097: 7 other devices →

What descends from it? (71)

See all 71

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080434	Intertan CHS Locking Plate System Prox Fem Plates/Screw	Smith & Nephew, Inc.	2008	35
K031401	Fixion Dynamic Hip Screw System (Fixion DHS)	Disco-O-Tech Medical Technologies, Ltd.	2003	32
K043233	Gotfried Physiological Hip (PH) Nail	Efratgo, Ltd. HI Tech Bio-Surgical	2005	1

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K080434 (Smith & Nephew, Inc., 2008) has gone furthest, with 35 descendants of its own.
7 other devices also cite its predicate K970097.

How does its category compare?

All JDO devices

JDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDO

1in 2023

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDO

Too few JDO 510(k)s in any year since 2007 to give a median.

Recalls per year · JDO

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDO

1in 2025

2007high 52 (2013) · low 1 (2008)2025

MAUDE reports naming product code JDO, 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	0	—	0	4
2008	2	—	0	1
2009	0	—	0	1
2010	0	—	0	6
2011	0	—	0	6
2012	0	—	0	9
2013	0	—	1	52
2014	1	—	0	15
2015	0	—	0	19
2016	1	—	0	44
2017	1	—	0	26
2018	1	—	0	18
2019	0	—	0	10
2020	1	—	0	19
2021	1	—	0	10
2022	1	—	0	3
2023	1	—	0	5
2024	0	—	0	2
2025	0	—	0	1
2026	1	—	0	—

What is it indicated for?

The GOTFRIED PC.C.P is intended to treat stable and unstable intertrochanteric, pertrochanteric, and base of neck hip 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/K983814 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983814: Gotfried Percutaneous Compression Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983814

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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