510(k) · Cleared

Cleared

Asian Intramedullary Hip Screw Nails

K050226510(k) SpecialCleared Feb 11, 200510-day reviewClass II21 CFR 888.3040

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

Smith & Nephew, Inc. · HWC Screw, Fixation, Bone

Cleared on Feb 11, 2005 as substantially equivalent to K040656 (Smith & Nephew, Inc., 2004) and 3 other predicates after a 10-day review. Its family tree reaches back 3 generations to 1998. 7 later devices descend from it.

Decided: Feb 11, 2005
Review: 10 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K981529 (1998). 9 ancestors in all, the oldest K952697 (1995). 7 later devices descend from it, 2 citing it directly.

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 deviceK050226 Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005
Descendant · cites it directly · 4 of its ownK092748 Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · Recalled
Descendant · 2 generations on · 1 of its ownK243364 TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024
Descendant · cites it directly · 1 of its ownK181640 X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
Descendant · 3 generations on · 0 of its ownK243608 TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK221621 Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010high 1 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all

K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · cites it directly4descendants
K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc. · 2024 · 2 generations on1descendant
K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018 · cites it directly1descendant
K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025 · 3 generations on0descendants
K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023 · 2 generations on0descendants

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)	K050226	Asian Intramedullary Hip Screw Nails	Smith & Nephew, Inc.	2005	—
+1	K092748	Sureshot Tan Nails and Accessories	Smith & Nephew, Inc.	2010	1
+2	K243364	TRIGEN META-TAN Trochanteric Antegrade Nail	Smith & Nephew, Inc.	2024	—
+1	K181640	X-BOLT Hip Fracture Fixation System	X-Bolt Orthopaedics	2018	—
+3	K243608	TRIGEN Stable Lock Nut & Washer	Smith & Nephew, Inc.	2025	—
+2	K221621	Pro-X1™ Trochanteric Nailing System	X-Bolt Orthopedics	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1998	1	0
1999	1	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2013	1	0
2018	1	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K050226, 1998–2025Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 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? (4)

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 …inindications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K040656, Smith & Nephew Intramedullary Hip Screw; K993289, Smith & Nephew Trauma Internal Fixation System; K040212, TdGen InterTAN Nail S…	Smith & Nephew, Inc.	2004	—
*	K993289	Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System Summary page 1 …al principles, and material composition when compared to the predicate devices cleared under the following submissions: K040656, Smith & Nephew Intramedullary Hip Screw; K993289, Smith & Nephew Trauma Internal Fixation System; K040212, TdGen InterTAN Nail System; and K952697, Ti Classic Compression Hip Scr…	Smith & Nephew, Inc.	1999	—
*	K040212	Trigen Intertan Summary page 1 …the predicate devices cleared under the following submissions: K040656, Smith & Nephew Intramedullary Hip Screw; K993289, Smith & Nephew Trauma Internal Fixation System; K040212, TdGen InterTAN Nail System; and K952697, Ti Classic Compression Hip Screw. Asian IMHS Hip Screw - SumS&E…	Smith & Nephew, Inc.	2004	6
*	K952697	Titanium Classic Compression Hip Screw System Summary page 1 …ollowing submissions: K040656, Smith & Nephew Intramedullary Hip Screw; K993289, Smith & Nephew Trauma Internal Fixation System; K040212, TdGen InterTAN Nail System; and K952697, Ti Classic Compression Hip Screw. Asian IMHS Hip Screw - SumS&E Pa…	Smith & Nephew Richards, Inc.	1995	—

Also cleared against K040656: 2 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K092748	Sureshot Tan Nails and Accessories	Smith & Nephew, Inc.	2010	4
K181640	X-BOLT Hip Fracture Fixation System	X-Bolt Orthopaedics	2018	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?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 9 months on median.
3 of the 9 ancestors have a recall of any class.
Of its descendants, K092748 (Smith & Nephew, Inc., 2010) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K040656.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Asian Intramedullary Hip Screws and accessories are for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050226: Asian Intramedullary Hip Screw Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050226

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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