510(k) · Cleared

Cleared

Dupuy S-Rom STD Hip Stem Prosthesis

K061221510(k) SpecialCleared Aug 28, 2006118-day reviewClass III21 CFR 888.3330

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

DePuy Orthopaedics, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Aug 28, 2006 as substantially equivalent to K961939 (Johnson & Johnson Professionals, Inc., 1996) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1994.

Decided: Aug 28, 2006
Review: 118 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K935452 (1994). 9 ancestors in all, the oldest K851422 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
2 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
1 generation backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
This deviceK061221 Dupuy S-Rom STD Hip Stem ProsthesisDePuy Orthopaedics, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−2	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
−1	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
0 (this device)	K061221	Dupuy S-Rom STD Hip Stem Prosthesis	DePuy Orthopaedics, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1991	1	0
1992	2	0
1994	1	0
1996	1	0

FIG. 1 — Lineage of K061221, 1994–2006Source: 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) Summary page 1 …ugh internal documentation) DEVICE DESCRIPTION: The subject DePuy S-ROM® Hip Stem is a line extension to the 36mm S-ROM® titanium stems previously cleared in K961939 and K851422. The line extension adds a +12L option to the previously cleared standard stem sizes 19 x 24 x 175 w/36mm neck…	Johnson & Johnson Professionals, Inc.	1996	—
*	K851422	S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip Summary page 1 …DePuy S-ROM® Femoral Hip Stem (I(961939, cleared August 13, 1996) DePuy S-ROM® STD Hip Stem Prostheses (K851422, cleared July 9, 1985 with additional modifications cleared throu…	Joint Medical Products Corp.	1985	—

Also cleared against K961939: 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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
None of the 9 ancestors has a recall.
8 other devices also cite its predicate K961939.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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	74	0	213
2008	9	57	13	762
2009	7	139	0	820
2010	6	167	84	3,348
2011	11	101	28	17,737
2012	4	76	21	24,601
2013	0	—	1	20,020
2014	0	—	0	16,494
2015	0	—	0	12,339
2016	0	—	1	7,872
2017	0	—	1	6,847
2018	0	—	1	6,388
2019	0	—	2	7,628
2020	0	—	1	4,538
2021	0	—	0	2,064
2022	0	—	0	1,617
2023	0	—	19	1,474
2024	0	—	0	1,168
2025	0	—	0	1,216
2026	0	—	0	—

What is it indicated for?

The DePuy S-ROM® Hip Stem Prosthesis is indicated for unceinented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061221: Dupuy S-Rom STD Hip Stem Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061221

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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