510(k) · Cleared

Cleared

GPC Intraheal Intramedullary Nailing System

K203811510(k) TraditionalCleared Feb 10, 2022409-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

Gpc Medical Limited · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 10, 2022 as substantially equivalent to K040336 (Synthes (Usa), 2004) and 6 other predicates after a 409-day review. Its family tree reaches back 3 generations to 2001.

Decided: Feb 10, 2022
Review: 409 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 7

Its longest line of descent runs back 3 generations to K013468 (2001). 16 ancestors in all, the oldest K960642 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
2 generations backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
1 generation backK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
This deviceK203811 GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K013468	Long Length Dyax Nail	Howmedica Osteonics Corp.	2001	1
−2	K034002	GAMMA3 Nail System	Howmedica Osteonics Corp.	2004	2
−1	K043431	GAMMA3 Nail System	Howmedica Osteonics Corp.	2005	—
0 (this device)	K203811	GPC Intraheal Intramedullary Nailing System	Gpc Medical Limited	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
2001	1	0
2003	2	0
2004	2	0
2005	1	0
2007	1	0
2010	1	0
2015	1	0

FIG. 1 — Lineage of K203811, 2001–2022Source: 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? (7)

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
*	K040336	Synthes (Usa) Lateral Entry Femoral Nail System Summary page 7 …Synthes Lateral Entry Femoral Nail 01. Multi Angle Femoral Nail (K040336) Locking Bolts 6.5mm (Self Tapping) Synthes Lateral…	Synthes (Usa)	2004	2
*	K143245	GPC Intramedullary Nailing Systems Summary page 7 …(K040336) (Synthes LFN) Locking Bolt 4.9mm, Self Tapping GPC Tibial Nail System Ex (K143245) and Synthes Trochanteric Fixation…	Gpc Medical Limited	2015	—
*	K011857	Synthes (Usa) Trochanteric Fixation Nail (TFN) System Summary page 7 …and Synthes Trochanteric Fixation Nail (TFN) SYSTEM (K011857) Page 2 of 8…	Synthes (Usa)	2001	7
*	K043431	GAMMA3 Nail System Summary page 8 …Page 3 of 8 GPC Medical Ltd 02. Proximal Hip Stabilizing Nail 3 (Short and Long) Gamma 3 Nail System (K043431) Cephalic Screw for Proximal Hip Stabilizing Nail 3…	Howmedica Osteonics Corp.	2005	—
*	K971783	Synthes Elastic Intramedullary Nail (Ein) System Summary page 8 …Synthes Elastic Intramedullary Nail 03. Elastic Nail Titanium (EIN) System (K971783) End Cap of Elastic Nail Titanium Synthes Elastic Intramedullary Nail…	Synthes (Usa)	1997	—
*	K053105	Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap Summary page 8 …d Cap of Elastic Nail Titanium Synthes Elastic Intramedullary Nail (EIN) End Cap K053105 SMT Schilling Metalltechnik GmbH 04. K. Wire…	Synthes (Usa)	2005	—
*	K100736	Kirschner and Guide Wires Summary page 8 …SMT Schilling Metalltechnik GmbH 04. K. Wire (K100736) NOTE: The end cap of each type of intramedullary nail is also part of the corresponding intramedullary nail and no separate pr…	Smt Schilling Metalltechnik GmbH	2010	—

Also cleared against K040336: 8 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 21 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
6 of the 16 ancestors have a recall of any class.
8 other devices also cite its predicate K040336.

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. 2022, 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?

GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below: Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below: - To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions. Proximal Hip…

Read the full statement (230 words)

GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:

Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:

- To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.

Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below:

Short Nail Indications: -

. Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion

. and tumor resections

Long Nail Indications: -

. Indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures,

impending pathological fractures, tumor resections and revision procedures.

Elastic Nails:

The Elastic Nail is indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

K-Wires:

K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system

All implants are for single use only.

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/K203811 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203811: GPC Intraheal Intramedullary Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203811

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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