510(k) · Cleared

Cleared

Titanium Classic Compression Hip Screw System

K952697510(k) TraditionalCleared Sep 12, 199591-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 Richards, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 12, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.

Decided: Sep 12, 1995
Review: 91 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

42 later devices descend from it, 4 citing it directly.

This deviceK952697 Titanium Classic Compression Hip Screw SystemSmith & Nephew Richards, Inc. · 1995
Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 4 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2005high 8 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 42 · See all

K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on11descendants
K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952697	Titanium Classic Compression Hip Screw System	Smith & Nephew Richards, Inc.	1995	—
+1	K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	2013	—
+2	K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2
+3	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+4	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+3	K180554	ANTHEM Fracture System	Globus Medical, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2010	1	0
2012	1	0
2013	2	0
2014	1	0
2017	2	0
2018	4	0
2020	1	0
2021	2	0
2022	4	0
2023	4	0
2024	8	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K952697, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	2013	33
K210837	Smith & Nephew Plates and Screws	Smith & Nephew, Inc.	2021	7
K050226	Asian Intramedullary Hip Screw Nails	Smith & Nephew, Inc.	2005	7
K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…	Smith & Nephew, Inc.	2022	2

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?

Of its descendants, K123055 (Smith & Nephew, Inc., 2013) has gone furthest, with 33 descendants of its own.

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	—

https://510kreport.com/device/K952697 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952697: Titanium Classic Compression Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952697

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026